Clinical trial • Phase III • Oncology
RILVEGOSTOMIG for Non-small cell lung cancer (non-squamous, metastatic; PD-L1 expressing)
Phase III trial of RILVEGOSTOMIG for Non-small cell lung cancer (non-squamous, metastatic; PD-L1 expressing).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (non-squamous, metastatic; PD-L1 expressing)
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody|Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 21-01-2025
Trial design
Randomised, arm b: pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion) administered intravenously in combination with platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed), followed by pembrolizumab monotherapy plus pemetrexed in maintenance (specific dose/schedule not stated in supplied data).-controlled Phase III trial in Italy, Netherlands, France and others.
- Randomised
- Yes
- Comparator
- Arm B: Pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion) administered intravenously in combination with platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed), followed by pembrolizumab monotherapy plus pemetrexed in maintenance (specific dose/schedule not stated in supplied data).
- Target Sample Size
- 637
Eligibility
Recruits 637 Vulnerable population selected (isVulnerablePopulationSelected = true). Provided materials include subject information sheets and informed consent forms for adult participants (multiple language versions listed). No explicit details on assent or additional consent procedures for minors or other vulnerable groups are provided in the supplied data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Provided materials include subject information sheets and informed consent forms for adult participants (multiple language versions listed). No explicit details on assent or additional consent procedures for minors or other vulnerable groups are provided in the supplied data.
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically documented non-squamous NSCLC.\n- Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.\n- Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.\n- Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.\n- Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.\n- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.\n- Adequate organ and bone marrow function."}
Exclusion criteria
- {"criterion_text":"- Presence of small cell and neuroendocrine histology components.\n- Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 Days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.\n- Any prior systemic therapy received for advanced or mNSCLC.\n- Prior treatment with an anti-PD-1 or anti-PD-L1 agent.\n- Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.\n- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n- Active primary immunodeficiency/active infectious disease(s).\n- Active tuberculosis infection."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Progression-free survival (PFS).","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Landmark overall survival (OS) rates","definition_or_measurement_approach":""}
- {"endpoint_text":"- Landmark progression-free survival (PFS) rates","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to second progression or death (PFS2)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall response rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Concentration of rilvegostomig in serum.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Presence of antidrug antibody (ADAs), titer and neutralizing antibodies for rilvegostomig.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of participants with maintained or improved physical functioning.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to deterioration (TTD) of global health status (GHS)/quality of life (QoL) and in pulmonary symptoms.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Adverse events (AEs) (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, and Eastern Cooperative Oncology Group (ECOG) performance status.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 637
- Recruitment Window Months
- 64
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms (SIS and ICF). Multiple language versions of SIS/ICF are listed (English, French, Polish, Dutch, Spanish, Italian, German, Hungarian, etc.). Specific consenting party: adult participants provide informed consent. Additional ICFs exist for optional genomic research and for pregnant partners; no further procedural details (assent processes or age-specific consent workflow) are provided in the supplied data.
Geography
- Total Number Of Participants
- 241
Italy
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 431
- Number Of Participants
- 17
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-12-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 349
- Number Of Participants
- 15
France
- Earliest CTIS Part Ii Submission Date
- 28-10-2024
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 402
- Number Of Participants
- 33
Poland
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 327
- Number Of Participants
- 21
Spain
- Earliest CTIS Part Ii Submission Date
- 09-12-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 358
- Number Of Participants
- 40
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 431
- Number Of Participants
- 36
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 360
- Number Of Participants
- 21
Germany
- Earliest CTIS Part Ii Submission Date
- 10-12-2024
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 358
- Number Of Participants
- 58
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Rilvegostomig
- Active Substance
- RILVEGOSTOMIG
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Investigational (prodAuthStatus 1)
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (EU/1/15/1024/002)
- Maximum Dose
- 200 mg (maxDailyDoseAmount indicated in product entry)
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Known medicinal product (prodAuthStatus 2)
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Known medicinal product (prodAuthStatus 2)
- Investigational Product Name
- PEMETREXED
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Known medicinal product (prodAuthStatus 2)
- Investigational Product Name
- INFLIXIMAB
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Known medicinal product (prodAuthStatus 2)
- Investigational Product Name
- MYCOPHENOLATE MOFETIL
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Known medicinal product (prodAuthStatus 2)
- Combination Treatment
- Yes
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