Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02151981 AURA3 | — | Progression Free Survival (PFS) by Investigator Assessment RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis). | Chemotherapy | 4.4 Months |
| Osimertinib 80mg | 10.1 Months | |||
| NCT02411448 RELAY | Carcinoma, Non-Small-Cell Lung | Number of Participants With Treatment-Emergent Adverse Events Cycle 1 Day 1 through End of Study (Up To 3 Years) | Part A: Ramucirumab + Erlotinib | 14 Participants |
| Part B: Placebo + Erlotinib | 225 Participants | |||
| Part B: Ramucirumab + Erlotinib | 221 Participants | |||
| NCT02411448 RELAY | Carcinoma, Non-Small-Cell Lung | Part B: Progression Free Survival (PFS) Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) | Part B: Placebo+ Erlotinib | 12.4 Months |
| Part B: Ramucirumab+ Erlotinib | 19.4 Months | |||
| NCT03521154 LAURA | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months | Osimertinib | 39.13 Months |
| Placebo | 5.55 Months | |||
| NCT04035486 FLAURA2 | Carcinoma, Non-Small-Cell Lung | Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only) From first dose date to 28 days following last dose, up to 45 months | Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 2 Participants |
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 0 Participants | |||
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 1 Participants | |||
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 9 Participants | |||
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 3 Participants | |||
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 0 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 2 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 0 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 8 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 4 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 0 Participants | |||
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 1 Participants | |||
| NCT04035486 FLAURA2 | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) (Randomized Component) Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.3 months) | Randomized: AZD9291 | 16.7 Months |
| Randomized: AZD9291 + Chemo | 25.5 Months | |||
| NCT04035486 FLAURA2 | Carcinoma, Non-Small-Cell Lung | Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component) Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.2 months). | Randomized: AZD9291 | 19.9 Months |
| Randomized: AZD9291 + Chemo | 29.4 Months | |||
| NCT04487080 MARIPOSA | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) From randomization to either disease progression or death whichever occurs first (up to 32.8 months) | Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib | 16.59 Months |
| Experimental: Arm A (Open-label): Amivantamab + Lazertinib | 23.72 Months | |||
| Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib | 18.46 Months | |||
| NCT04765059 COMPEL | Carcinoma, Non-Small-Cell Lung | Progression Free Survival (PFS) From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month) | Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin | 8.4 Months |
| Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin | 4.4 Months | |||
| NCT04816214 GEOMETRY-E | Carcinoma, Non-Small-Cell Lung | Run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) Up to 21 Days | Run-in Part: Capmatinib + Osimertinib | 0 Participants |