Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atezolizumab · 2 trials · 2 indications
Proportion of patients presenting Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) based on the Investigator's assessment according to standard RECIST criteria v.1.1.
Proportion of patients with a partial response \[PR\] or complete response \[CR\] per RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| ATEZOLIZUMAB | EXPERIMENTAL | Atezolizumab will be administered at a flat dose of 1200 mg by intravenous route. Atezolizumab will be delivered in 250-mL 0.9% NaCl (sodium chloride) intravenous (IV) infusion bags. The administration will be repeated every 3 weeks (21 \[± 3\] days). The initial dose will be delivered over 60 (± 15) minutes. In case the first infusion is tolerated without any infusion-associated AEs the second infusion may be delivered over 30 (± 10) minutes. If the second 30 minutes infusion is well tolerated all the subsequent infusions may be administered over 30 (± 10) minutes. The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled. |
| Module 1 - Atezolizumab | EXPERIMENTAL | Genomically selected populations will all receive the same drug * Arm 1A: BRCA1 or BRCA2 mutations * Arm 1B: MLH1, MSH2, MSH6, or PMS2 mutations * Arm 1C: tumors with POLE mutation, POLD1 mutation * Arm 1D: hypermutated tumors * Arm 1E: tumors with other mutations in DNA-repair genes * Arm 1F: tumors with amplified PDL1 * Arm 1G: tumours with CDK12 mutations Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1000 subjects will need to be screened in part A in order to enroll 120 patients in part B of module 1. |
| Module 2 - Futibatinib | EXPERIMENTAL | Genomically selected populations will all receive the same drug * Arm 2A: Known pathogenic FGFR1-3 mutations * Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations. * Arm 2C: Highly amplified FGFR1-3 with high FGFR1-3 mRNA (with the exception of gastric and breast cancer) * Arm 2D: Highly amplifiedFGFR1-3 without high FGFR1-3 mRNA (with the exception of gastric and breast cancer) Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 2000 subjects will need to be screened in part A in order to enroll 80 patients in part B of module 2. |
| Module 3 - Amivantamab | EXPERIMENTAL | Genomically selected populations will all receive the same drug * Arm 3A: kinase domain mutations/ MET fusion-genes (including intragene exon skipping MET-MET fusions) * Arm 3B: MET copy number gain (equivalent CNG ≥6) (exception: colorectal cancer) * Arm 3C: EGFR mutations (exception: primary lung malignancies) Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1725 subjects will need to be screened in part A in order to enroll 69 patients in part B of module 3. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | Atezolizumab will be administered on Day 1 every 21 days (+/- 3 days). |
| Futibatinib | DRUG | 20 mg administered orally, once daily (QD) continuously in 28-day cycles. |
| Amivantamab | DRUG | 1050 mg administered IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles) |
Inclusion Criteria: * Locally advanced, relapsed or metastatic non-small cell lung cancer (NSCLC) - stage IIIB/IV according to 7th International Association for the Study of Lung Cancer (IASLC) classification * Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) with rare histo...
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