Name | Type | Description | Interventions |
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Cohort A: Alectinib 600 Milligrams (mg) | Experimental | This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Enrollment to Cohort A is complete. | |
Cohort B: Dose Finding Phase (DFP) Alectinib | Experimental | This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose.
Enrollment to Cohort B is complete. | |
Cohort B: Dose Expansion Phase (DEP) Alectinib | Experimental | This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death.
Enrollment to Cohort B is complete. | |
Cohort C: Atezolizumab 1200 mg | Experimental | This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death.
Enrollment to Cohort C is complete. | |
Cohort C: Pemetrexed, Cisplatin or Carboplatin | Active Comparator | This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care.
Enrollment to Cohort C is complete. | - Pemetrexed
- Cisplatin
- Carboplatin
|
Cohort C: Gemcitabine, Cisplatin or Carboplatin | Active Comparator | This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D.
Enrollment to Cohort C is complete. | - Cisplatin
- Carboplatin
- Gemcitabine
|
Cohort D: Entrectinib 600 Milligrams (mg) | Experimental | This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Enrollment to Cohort D is complete. | |
Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib | Experimental | This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period. | - Atezolizumab
- Cobimetinib
- Vemurafenib
|
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed | Experimental | This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death. | - Atezolizumab
- Pemetrexed
- Carboplatin
- Bevacizumab
|