Clinical trial • Phase II • Oncology|Respiratory
Durvalumab for Non-small cell lung cancer (stage III, N2) | Resectable locally advanced non-small cell lung cancer
Phase II trial of Durvalumab for Non-small cell lung cancer (stage III, N2) | Resectable locally advanced non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory
- Trial Disease
- Non-small cell lung cancer (stage III, N2) | Resectable locally advanced non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-01-2024
- First CTIS Authorization Date
- 17-04-2024
Trial design
Randomised, open-label, arms (radiotherapy regimens) per randomisation: a: 20x2 gy radiotherapy (weekdaily, 4 weeks); b: 5x5 gy radiotherapy (weekdaily, 1 week); c: 3x8 gy radiotherapy (on alternate days, 1 week). all subjects receive neoadjuvant chemotherapy (cisplatin/docetaxel or permitted alternatives) and peri-operative durvalumab; arms differ by radiotherapy regimen.-controlled Phase II trial across 1 site in Germany, Switzerland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arms (radiotherapy regimens) per randomisation: A: 20x2 Gy radiotherapy (weekdaily, 4 weeks); B: 5x5 Gy radiotherapy (weekdaily, 1 week); C: 3x8 Gy radiotherapy (on alternate days, 1 week). All subjects receive neoadjuvant chemotherapy (cisplatin/docetaxel or permitted alternatives) and peri-operative durvalumab; arms differ by radiotherapy regimen.
- Target Sample Size
- 80
Eligibility
Recruits 80 adults.
Inclusion criteria
- {"criterion_text":"- Histologically (cytology is accepted if histology is not possible) confirmed NSCLC (adeno-, squamous-, large cell carcinoma, or NSCLC not otherwise specified (NOS)) irrespective of genomic aberrations or PD-L1 expression status\n- Tumor stage T1-4>7 N2 M0 (i.e. T1-3 N2 or T4 N2 but T4 only allowed if due to size > 7cm, not allowed if due to invasion or nodule in different ipsilateral lobe), according to the TNM classification, 8th edition, December 2016. Mediastinal lymph node staging has to follow the process chart.\n- Age 18-75 years at time of registration\n- WHO performance status 0-1\n- Adequate organ function (incl. eGFR ≥ 60 mL/min)"}
Exclusion criteria
- {"criterion_text":"- Presence of any distant metastasis or N3 disease. Brain metastases have to be excluded by CT or MRI\n- Sulcus superior tumors (Pancoast tumors) or T4 for any other reason than size >7cm\n- Any previous treatment for NSCLC\n- Any previous treatment with immune checkpoint inhibitors, including durvalumab\n- Previous radiotherapy to the chest (with the exception of tangential breast irradiation with minimal dose to lung and mediastinum, and superficial orthovoltage or electron irradiation of localized skin lesions)\n- Preexisting peripheral neuropathy (> Grade 1)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event-free survival (EFS) at 12 months","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Event-free survival (EFS)\n- Recurrence-free survival (RFS) after R0 resection\n- Overall survival (OS)\n- Objective response (OR) after neoadjuvant chemotherapy\n- OR after neoadjuvant immunotherapy and immune-modulatory radiotherapy\n- Pathological complete response (pCR)\n- Local major pathological response (MPR)\n- Overall major pathological response (oMPR)\n- Rate of nodal down-staging to < ypN2\n- Complete resection rate\n- Pattern of recurrence (loco-regional, distant)\n- Adverse events (AEs) and surgical complications\n- Delay in surgery\n- Postoperative 30-day mortality","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 93
- Consent Approach
- Informed consent and screening. Adults (age 18-75) provide informed consent. No assent process or languages for consent specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 80
Germany
- Earliest CTIS Part Ii Submission Date
- 21-02-2024
- Latest Decision Or Authorization Date
- 15-08-2024
- Processing Time Days
- 176
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Klinik für Radioonkologie
- Principal Investigator Name
- Cihan Gani
- Principal Investigator Email
- roinfo@med.uni-tuebingen.de
- Contact Person Name
- Cihan Gani
- Contact Person Email
- roinfo@med.uni-tuebingen.de
- Number Of Participants
- 10
Switzerland
- Number Of Sites
- 0
Sponsor
Primary sponsor
- Full Name
- Swiss Group for Clinical Cancer Research
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- CROLLL GmbH Auftragsforschungsinstitut (CRO)
- Responsibilities
- sponsorDuties codes: 1, 12
Third parties
- {"country":"Switzerland","full_name":"Universitaetsspital Basel","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"CROLLL GmbH Auftragsforschungsinstitut (CRO)","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Universitaetsspital Basel (Zlf, Hebelstrasse 20)","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- Durvalumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Authorisation Status
- Authorised
- Frequency
- Adjuvant: 13 cycles of 28 days; Neoadjuvant durvalumab concurrent with radiotherapy (start corresponds to day 64 / week 10).
- Maximum Dose
- 1500 mg (max daily); 21000 mg (max total)
- Investigational Product Name
- Doce onkovis 20 mg/ ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Docetaxel
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Authorisation Status
- Authorised
- Frequency
- Neoadjuvant chemotherapy: 3 cycles of 21 days (docetaxel part of cisplatin/docetaxel regimen); alternative chemo permitted if AEs.
- Maximum Dose
- 85 mg/m2 (max daily); 255 mg/m2 (max total)
- Investigational Product Name
- Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Cisplatin
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Authorisation Status
- Authorised
- Frequency
- Neoadjuvant chemotherapy: 3 cycles of 21 days (cisplatin/docetaxel regimen)
- Maximum Dose
- 100 mg/m2 (max daily); 300 mg/m2 (max total)
- Investigational Product Name
- Carboplat onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Carboplatin
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Frequency
- Alternative to cisplatin if AEs in cycle 1 or 2 (carboplatin AUC 6 allowed)
- Maximum Dose
- 400 mg/m2 (max daily); 800 mg/m2 (max total)
- Investigational Product Name
- Pemetrexed medac 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Pemetrexed
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Frequency
- Permitted in cycle 2 and/or 3 as alternative if AEs require discontinuation of docetaxel (pemetrexed 500 mg/m2)
- Maximum Dose
- 500 mg/m2 (max daily); 1000 mg/m2 (max total)
- Investigational Product Name
- Paclitaxel onkovis, 6 mg/ml, Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Paclitaxel
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Frequency
- Permitted in cycle 2 and/or 3 as alternative if AEs require discontinuation of docetaxel (paclitaxel 200 mg/m2)
- Maximum Dose
- 200 mg/m2 (max daily); 400 mg/m2 (max total)
- Investigational Product Name
- Vinorelbin onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Vinorelbine tartrate
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised
- Frequency
- Permitted in cycle 2 and/or 3 as alternative if AEs require discontinuation of docetaxel (vinorelbine 30 mg/m2)
- Maximum Dose
- 30 mg/m2 (max daily); 120 mg/m2 (max total)
- Combination Treatment
- Yes
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