Clinical trial • Phase II/III • Oncology

Alectinib for Advanced or metastatic non-small cell lung cancer

Phase II/III trial of Alectinib for Advanced or metastatic non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced or metastatic non-small cell lung cancer
Trial Stage
Phase II/III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
11-06-2024

Trial design

Platinum-based chemotherapy comparator (atezolizumab compared with platinum-based chemotherapy in Cohort C). SmPC/comparator products referenced in CTIS documents include carboplatin, pemetrexed, cisplatin, docetaxel, gemcitabine (standard chemotherapies listed in product/SmPC documents). Specific doses and schedules are not specified in the available data.-controlled, adaptive Phase II/III trial in Belgium, Germany, Spain and others.

Comparator
Platinum-based chemotherapy comparator (atezolizumab compared with platinum-based chemotherapy in Cohort C). SmPC/comparator products referenced in CTIS documents include carboplatin, pemetrexed, cisplatin, docetaxel, gemcitabine (standard chemotherapies listed in product/SmPC documents). Specific doses and schedules are not specified in the available data.
Adaptive
True, contains dose-escalation elements (e.g., DLTs and escalating alectinib doses in RET+ patients in Cohort B; Cohort G evaluates two doses of divarasib). Interim or stopping rules are not detailed in the available data.
Biomarker Stratified
True: selection/stratification is by actionable somatic mutations detected by the FoundationOne Liquid Companion Diagnostic (F1LCDx) — cohorts defined by ALK+, RET+, ROS1+, BRAF V600+, EGFR exon 20+, KRAS G12C+; Cohort C is stratified by blood tumor mutational burden (bTMB) with primary PP1 and secondary PP2 populations.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
344

Eligibility

Recruits 344 Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided for multiple cohorts (documents listed in the CTIS record). No explicit assent procedures are described in the available data; informed consent is obtained using the ICF/SIS documents..

Pregnancy Exclusion
Women who are pregnant or lactating
Vulnerable Population
Vulnerable population selected (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided for multiple cohorts (documents listed in the CTIS record). No explicit assent procedures are described in the available data; informed consent is obtained using the ICF/SIS documents.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC\n- Measurable disease (as defined by RECIST, v1.1)\n- Adequate recovery from most recent systemic or local treatment for cancer\n- Adequate organ function\n- Life expectancy >=12 weeks\n- For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception"}

Exclusion criteria

  • {"criterion_text":"- Inability to swallow oral medication\n- Women who are pregnant or lactating\n- Symptomatic, untreated CNS metastases Patients with treated and/or asymptomatic brain metastases may still be eligible for treatment on the study depending on individual cohort requirements; see the cohort-specific appendices for details regarding eligibility\n- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate ≥ 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ of breast, or Stage I uterine cancer\n- Significant cardiovascular disease\n- Known active or uncontrolled HIV infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Investigator-assessed ORR based on confirmed objective response (Cohorts A, B, D, and F)","definition_or_measurement_approach":"Investigator-assessed objective response rate based on confirmed objective response."}
  • {"endpoint_text":"- 2. Investigator-assessed PFS according to RECIST v1.1 (Cohort C) in bTMB the primary population of patients with a bTMB level equal to or greater than the higher validated cutoff (PP1)","definition_or_measurement_approach":"Investigator-assessed progression-free survival per RECIST v1.1 in the bTMB primary population (bTMB ≥ validated cutoff)."}
  • {"endpoint_text":"- 3. Investigator-assessed 12-month time in response (TIR) per RECIST v1.1 (Cohort E)","definition_or_measurement_approach":"Investigator-assessed time in response at 12 months measured per RECIST v1.1."}
  • {"endpoint_text":"- 4. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), (Cohorts G)","definition_or_measurement_approach":"Safety assessment: incidence, type and severity of AEs graded by NCI CTCAE v5.0."}
  • {"endpoint_text":"- 5. Change from baseline in targeted vital signs, clinical laboratory test results, ECG parameters (Cohorts G)","definition_or_measurement_approach":"Changes from baseline in specified vital signs, labs and ECG parameters as measured during study assessments."}
  • {"endpoint_text":"- 6. Tolerability of treatment as assessed through use of the NCI PRO-CTCAE (Cohort G) Frequency of patients' response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC Item List (IL46) (Cohort G)","definition_or_measurement_approach":"Patient-reported tolerability assessed via NCI PRO-CTCAE and a single-item EORTC measure (IL46) capturing degree of symptom bother."}

Secondary endpoints

  • {"endpoint_text":"- 1. Investigator-assessed DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)","definition_or_measurement_approach":"Duration of response (DOR), clinical benefit rate (CBR), and progression-free survival as assessed by investigator per RECIST v1.1."}
  • {"endpoint_text":"- 2. IRF-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)","definition_or_measurement_approach":"Independent review facility-assessed ORR, DOR, CBR, and PFS per RECIST v1.1."}
  • {"endpoint_text":"- 3. IRF-assessed PFS, ORR, and DOR according to RECIST v1.1 (Cohort C and F)","definition_or_measurement_approach":"IRF-assessed PFS, ORR and DOR per RECIST v1.1 for Cohorts C and F."}
  • {"endpoint_text":"- 4. Investigator-assessed ORR, and DOR according to RECIST v1.1 (Cohort C)","definition_or_measurement_approach":"Investigator-assessed ORR and DOR per RECIST v1.1 in Cohort C."}
  • {"endpoint_text":"- 5. Investigator- and IRF-assessed time to CNS progression according to RECIST v1.1 (Cohort D)","definition_or_measurement_approach":"Time to confirmed CNS progression assessed by investigator and IRF per RECIST v1.1."}
  • {"endpoint_text":"- 6. OS (Cohorts A, B, D, E, and F)","definition_or_measurement_approach":"Overall survival measured from randomization/enrollment to death from any cause."}
  • {"endpoint_text":"- 7. Investigator-assessed PFS rates at 6-month and 1-year landmark timepoints (Cohort C)","definition_or_measurement_approach":"PFS rates at 6-month and 1-year landmark timepoints assessed by investigator."}
  • {"endpoint_text":"- 8. Incidence, type, and severity of adverse events (based on the NCI CTCAE v4.0)(Cohorts A-F)","definition_or_measurement_approach":"AE incidence, type and severity graded by NCI CTCAE v4.0 for Cohorts A-F."}
  • {"endpoint_text":"- 9. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified IMPs (Cohorts A, B, D, E, and F)","definition_or_measurement_approach":"Changes in vital signs, physical exam findings and laboratory results collected during and after IMP administration."}
  • {"endpoint_text":"- 10. DLTs, if any, associated with alectinib at escalating doses in RET+ patients (Cohort B)","definition_or_measurement_approach":"Dose-limiting toxicities associated with escalating alectinib doses in RET+ patients."}
  • {"endpoint_text":"- 11. PK parameters of alectinib in RET+ patients (Cohort B)","definition_or_measurement_approach":"Pharmacokinetic parameters of alectinib measured in RET+ patients."}
  • {"endpoint_text":"- 12. Population PK analysis for entrectinib (Cohort D)","definition_or_measurement_approach":"Population pharmacokinetic analysis for entrectinib."}
  • {"endpoint_text":"- 13. Time to confirmed deterioration (TTCD) in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain, as measured by the symptoms in lung cancer (SILC) (Cohort A, B, D, E, F)","definition_or_measurement_approach":"TTCD in patient-reported cough, dyspnea, and chest pain measured by SILC questionnaire."}
  • {"endpoint_text":"- 14. Proportion of patients who improved compared with baseline in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain and TTD as measured by SILC (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Proportion of patients with symptom improvement vs baseline per SILC and time to deterioration."}
  • {"endpoint_text":"- 15. Proportion of patients presenting with measurable CNS disease at baseline who improve compared with baseline in patient-reported cognitive function, fatigue, health-related quality of life (HRQoL), headache, and vision disorder per the corresponding scales of the EORTC QLQ-C30 and BN20 (Cohort D)","definition_or_measurement_approach":"Proportion improving in cognitive function, fatigue, HRQoL, headache, vision as measured by EORTC QLQ-C30 and BN20 scales."}
  • {"endpoint_text":"- 16. Mean change from baseline in HRQoL, patient functioning, and symptoms as measured by the EORTC QLQ-C30, QLQ-LC-13 or SILC (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Mean change from baseline in HRQoL and symptoms measured by EORTC QLQ-C30, QLQ-LC-13 or SILC."}
  • {"endpoint_text":"- 17. Health status as assessed by the EQ-5D-5L questionnaire (Cohorts A, B, C, D, E, and F)","definition_or_measurement_approach":"Health status measured by EQ-5D-5L questionnaire."}
  • {"endpoint_text":"- 18. Relationship between circulating biomarkers related to alectinib exposure and efficacy (Cohorts A and B), to atezolizumab efficacy (Cohort C) to entrectinib efficacy (Cohort D), atezo + cobi + vem efficacy (Cohort E), and atezo + bev + carboplatin + pemetrexed efficacy (Cohort F)","definition_or_measurement_approach":"Analysis of circulating biomarkers in relation to exposure and efficacy for respective cohorts."}
  • {"endpoint_text":"- 19. OS in bTMB PP1 (Cohort C)","definition_or_measurement_approach":"Overall survival in the bTMB primary population (PP1) for Cohort C."}
  • {"endpoint_text":"- 20. Investigator-assessed PFS according to RECIST v1.1 in bTMB the secondary population of all patients who are bTMB-positive, which is the intent-to-treat (ITT) population in this cohort (PP2) [Cohort C]","definition_or_measurement_approach":"Investigator-assessed PFS per RECIST v1.1 in the bTMB-positive ITT population (PP2) for Cohort C."}
  • {"endpoint_text":"- 21. OS in bTMB PP2 (Cohort C)","definition_or_measurement_approach":"Overall survival in the bTMB secondary population (PP2) for Cohort C."}
  • {"endpoint_text":"- 22. Investigator and IRF-assessed ORR, DOR, and PFS per RECIST v1.1 (Cohort E)","definition_or_measurement_approach":"Investigator- and IRF-assessed ORR, DOR, and PFS per RECIST v1.1 in Cohort E."}
  • {"endpoint_text":"- 23. Investigator-assessed DOR and PFS per RECIST v1.1 (Cohort F)","definition_or_measurement_approach":"Investigator-assessed duration of response and PFS per RECIST v1.1 for Cohort F."}
  • {"endpoint_text":"- 24. 9-month TIR (Cohort E)","definition_or_measurement_approach":"9-month time in response for Cohort E per RECIST v1.1."}
  • {"endpoint_text":"- 25. 12-month TIR (Cohort E)","definition_or_measurement_approach":"12-month time in response for Cohort E per RECIST v1.1."}
  • {"endpoint_text":"- 26. Serum concentration of atezo at specified timepoints (Cohort E and F)","definition_or_measurement_approach":"Serum concentrations of atezolizumab measured at predefined timepoints."}
  • {"endpoint_text":"- 27. Presence of ADAs against atezo during the study relative to the presence of ADAs at baseline (Cohort E and F)","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) against atezolizumab during study versus baseline."}
  • {"endpoint_text":"- 28. Plasma concentrations of divarasib at specified timepoints","definition_or_measurement_approach":"Plasma concentrations of divarasib measured at specified timepoints."}

Recruitment

Planned Sample Size
344
Recruitment Window Months
129
Consent Approach
Informed consent is required using subject information sheets and informed consent forms (L1_SIS and ICF documents exist for multiple cohorts and contexts, including pregnant-partner cohort documents). Multiple cohort-specific ICFs are included in the CTIS documents. Translations of study documents/protocol synopsis are available in French, Polish, Spanish and protocol synopses also available in Italian, Dutch and German; English-language materials are available as well. No specific assent process is described in the available data.

Geography

Total Number Of Sites
40
Total Number Of Participants
344

Belgium

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
25
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
UZ Leuven
Department Name
Respiratory Oncology
Contact Person Name
Christophe Dooms
Contact Person Email
datanursingreo@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Frank Aboubakar
Site Name
UZ Brussel
Department Name
Oncology
Contact Person Name
Lore Decoster

Germany

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Asklepios Klinik Gauting GmbH
Department Name
Asklepios Fachkliniken München-Gauting Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Klinikum Esslingen GmbH
Department Name
KLINIK FÜR Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling
Site Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Department Name
Innere Medizin III: Hämatologie/Onkologie/ Palliativmedizin
Contact Person Name
Natalia Heinz

Spain

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
19
Number Of Sites
17
Number Of Participants
73

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Contact Person Name
Luis Paz Arez Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Institut Catala D'oncologia
Department Name
Oncología
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
ernestnadal@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncología
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncología
Contact Person Name
Amelia Insa Molla
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncología
Contact Person Name
Belén Rubio Viqueira
Contact Person Email
belen.rubio@quironsalud.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncología
Contact Person Name
Gema García Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncología
Contact Person Name
Noemí Reguart Aransay
Contact Person Email
NREGUART@clinic.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología
Contact Person Name
Rosa Álvarez Álvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncología
Contact Person Name
Rafael López López
Contact Person Email
rafa.lopez.lopez@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología
Contact Person Name
Reyes Bernabé Caro
Contact Person Email
reyesbernab@yahoo.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncología
Contact Person Name
Teresa Morán Bueno
Contact Person Email
mmoran@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Contact Person Name
Pilar Garrido López
Contact Person Email
pilargarridol@gamil.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncología
Contact Person Name
Bartomeu Massuti Sureda
Contact Person Email
bmassutis@seom.org

Poland

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
03-07-2024
Processing Time Days
41
Number Of Sites
6
Number Of Participants
40

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Andrzej Każarnowicz
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Rafał Dziadziuszko
Contact Person Email
rafald@gumed.edu.pl
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej
Contact Person Name
Grzegorz Czyżewicz
Contact Person Email
czyzeg@szpitaljp2.krakow.pl
Site Name
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Department Name
Oddział III - Chorób Płuc z Pododdziałem Onkologicznym
Contact Person Name
Aleksandra Szczęsna
Contact Person Email
ola_szczesna@outlook.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl

Italy

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
25
Number Of Sites
9
Number Of Participants
41

Sites

Site Name
European Institute Of Oncology S.r.l.
Department Name
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Contact Person Name
Filippo De Marinis
Contact Person Email
filippo.demarinis@ieo.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.C.D.U. di Oncologia Toracica
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Department Name
Oncologia Medica
Contact Person Name
Lucia Bonomi
Contact Person Email
lbonomi@asst-pg23.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
ASST DI MONZA
Contact Person Name
Diego Cortinovis
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Irccs Centro Di Riferimento Oncologico (CRO)
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
Contact Person Name
Stefano Panni
Contact Person Email
stefano.panni@asst-cremona.it
Site Name
San Camillo Forlanini Hospital
Department Name
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Contact Person Name
Serena Ricciardi
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Contact Person Name
Alessandro Morabito

France

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
20
Number Of Sites
2
Number Of Participants
90

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pneumology
Contact Person Name
Charles Ricordel
Contact Person Email
charles.ricordel@chu-rennes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumology
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
1
Name
Almac Clinical Technologies LLC
Responsibilities
3
Name
Icon Development Solutions LLC
Responsibilities
4

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Exco Intouch Limited","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"15","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Alectinib
Modality
Small molecule
Investigational Product Name
Entrectinib
Modality
Small molecule
Investigational Product Name
Atezolizumab
Modality
Monoclonal antibody
Investigational Product Name
Cobimetinib
Modality
Small molecule
Investigational Product Name
Vemurafenib
Modality
Small molecule
Investigational Product Name
Bevacizumab
Modality
Monoclonal antibody
Investigational Product Name
Carboplatin
Modality
Small molecule
Investigational Product Name
Pemetrexed
Modality
Small molecule
Investigational Product Name
Divarasib
Modality
Small molecule
Combination Treatment
Yes

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