Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution
Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA
Either have not started a prior EGFR TKI therapy or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy > 6 months prior to study start is acceptable)
Disqualifiers
Pregnant or lactating women
Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
Any evidence of clinically significant interstitial lung disease
Trial design
Treatments tested in this trial
- Osimertinib
- Carboplatin
- Pemetrexed
Treatment groups
571 Participants
are divided into 2 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
AstraZeneca
Collaborator
Guardant Health, Inc.
Collaborator
Source ClinicalTrials.gov