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Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

ConditionMetastatic Non-small Cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Osimertinib

    Drug

    80mg orally daily

  • Carboplatin

    Drug

    Carboplatin (AUC 5 IV q 3 weeks)

  • Pemetrexed

    Drug

    Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles

Treatment groups

571 Participants
are divided into 2 treatment groups
Group A: Osimertinib aloneExperimental treatment 1 intervention
Group B: Osimertinib plus Carboplatin and PemetrexedExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determine the progression-free survival

As the primary endpoint for the treatment comparison, it is the duration of time from randomization to the time of disease progression (in the CNS or systemically) or death. In addition, as a secondary endpoint, PFS is measured from the start of treatment to disease progression or death. Intracranial progression-free survival (PFS) is defined as the duration of time from time of randomization to time of progression (in the CNS) or death, whichever occurs first. Overall survival (OS) is defined as the duration of time from first treatment to time of death.

Time frame
2 years

Secondary outcomes

1

overall response rate

Best overall response rate (confirmed partial and complete responses) will be assessed as part of this study. All responses must be confirmed on subsequent scan to be considered a true response. Tumor response will be assessed using RECIST 1.1. For patients enrolled in the randomized treatment portion of study. Confirmation of baseline measurable disease for all patients will be determined via investigator review.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

AstraZeneca

Collaborator

Guardant Health, Inc.

Collaborator

Source ClinicalTrials.gov
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