Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

Conditions

• Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

May 28, 2020

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

571 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Osimertinib alone
  All patients will receive osimertinib 80mg orally daily. Subjects randomized to Arm A may be dispensed osimertinib for 2 cycles from Cycle 4 onward. Patients will be required to complete a pill diary beginning at Cycle 4.
• Experimental: Osimertinib plus Carboplatin and Pemetrexed
  All patients will receive osimertinib 80mg orally daily. Patients receive Carboplatin (AUC 5 IV q 3 weeks) and Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles followed by pemetrexed maintenance from cycle 8 onwards. Patients will be required to complete a pill diary beginning at Cycle 4.

Primary Outcome Measure

Determine the progression-free survival [ Time Frame: 2 years ]

Central Contacts

• Helena Yu, MD
  646-608-2252
  [email protected]
• Gregory Riely, MD, PhD
  646-608-3913

Locations (18)

Find similar trials in Sacramento, CA

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