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NCT04487080 (Amivantamab in EGFR-mutant Non-Small Cell Lung Cancer): BVCT ex-ante prediction vs. reported outcome

On 5 Apr 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 26 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably insufficient (negligible OS benefit).

Clinical Trial

NCTID
NCT04487080
Acronym
MARIPOSA
Drug Name
Amivantamab
Drug MoA
bispecific antibody anti-EGFR and anti-MET inhibitor
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
EGFR-mutant Non-Small Cell Lung Cancer (NSCLC)
Human Patients
1074
Sponsor
Johnson & Johnson
Phase
Phase 3

Prediction of , index 971

Prospective Prediction
Prediction Index
971
Prediction Date
Commercial Prediction
FAILURE (non-superior)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
721 days in advance
Readout Data Interpretation
amivantamab + lazertinib achieve statistically significant clinical benefit in mOS (HR = 0.75 p <0.005) compared with osimertinib; In contrast amivantamab + lazertinib has 12% grade >=3 SAE; inferior to 1% grade >=3 SAE for osimertinib; The overall clinical benefit of amivantamab + lazertinib is grade 1 negligible (according to ESMO-MAGNITUDE OF CLINICAL BENEFIT SCALE V1.1 EVALUATION FORM 2A (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient (negligible OS benefit)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Phase
Phase 3
Status
Active not recruiting
Enrollment
1074
Lead sponsor
Janssen Research & Development, LLC
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG: Amivantamab; DRUG: Osimertinib; DRUG: Lazertinib; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-09-30
Primary completion
2023-08-11
Completion
2028-02-16
Results first posted
2024-10-09
Primary outcomes
  • 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))

NCT04487080 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials