A randomized, open-label, phase 3 study to evaluate zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for the first-line treatment of patients with metastatic non–small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations
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Une étude randomisée, en ouvert, de phase 3 visant à évaluer le Zimberelimab et le Domvanalimab en association avec la chimiothérapie par rapport au Pembrolizumab avec la chimiothérapie pour le traitement de première ligne des patients atteints de cancer du poumon non à petites cellules métastatique sans anomalies tumorales génomiques du récepteur du facteur de croissance épidermique ou de la kinase lymphomateuse anaplasique
Adult, life expectancy no less than 3 months, non small cells lung cancer, stage IV, EGFR non mutation, ALK non mutation
Exclusion criteria
mixed histology, pregnant participant or breastfeeding, participant who received a previous treatment in first line metastatic, participant who received a previous treatment anti-PD-1 or anti-PD-L1 in adjuvant or neo-adjuvant.
Cohorts
Proposed Therapy or Intervention
Study intervention
Zimberelimab, Domvanalimab, Pembrolizumab
Cohorts
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Data not available
Current data since :
May 08, 2024 00:16
Centre intégré de santé et de services sociaux de la Montérégie-Centre
Data not available
Current data since :
March 13, 2024 00:30
Centre intégré de santé et de services sociaux des Laurentides
Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Unknown
Pembrolizumab (PEMBRO) + Chemotherapy
Data not available
Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Unknown
Zimberelimab (ZIM) + Chemotherapy
Data not available
Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Participants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Pembrolizumab (PEMBRO) + Chemotherapy
Recruitment status
unknown
Participants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Zimberelimab (ZIM) + Chemotherapy
Recruitment status
unknown
Participants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle.
Choice of chemotherapy is dependent on histology.
Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities.
Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Current data since :
April 30, 2024 20:00
Study's description
Study description
Study summary
Zimberelimab and domvanalimab are antibodies that could block the interaction between certain proteins expressed on cancer cells and immune cells, relieving the suppression of the immune system and boosting the immune response against cancer cells. The main purpose of this study is to determine whether the investigational drugs zimberelimab (also known as AB122 or ZIM) alone or with domvanalimab (also known as AB154 or DOM) in combination with chemotherapy are safe and effective when given to participants with the type of cancer you have. The study will also try to understand how the investigational drugs with chemotherapy compare to pembrolizumab (the standard drug for those with NSCLC) with chemotherapy for people with your type of cancer. This study will also try to find out your quality of life and health status during the study.
There will be 3 groups in this study:
Group A: If you are randomized into Group A, you will receive a combination of zimberelimab, domvanalimab, and platinum doublet chemotherapy for your treatment.
Group B: If you are randomized into Group B, you will receive a combination of pembrolizumab and platinum doublet chemotherapy for your treatment.
Group C: If you are randomized into Group C, you will receive a combination of zimberelimab and platinum doublet chemotherapy for your treatment.
The platinum doublet chemotherapy you will receive will be determined by your doctor. Depending on the specific type of your cancer and your medical needs, you will receive chemotherapy drugs from one of the following combinations: carboplatin with paclitaxel, carboplatin with nab-paclitaxel, carboplatin with pemetrexed, or cisplatin with pemetrexed for up to 4 cycles. After the initial 4 cycles, depending on the specific type of your cancer, you may continue to receive chemotherapy of pemetrexed until your disease worsens or you could no longer tolerate the drug.
Locations
Locations
Main center
CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DU BAS-SAINT-LAURENT
