Erlotinib for Non-Small Cell Lung Cancer

Recruiting at1597 trial locations

Overseen by Ramaswamy Govindan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Ramaswamy Govindan

Principal Investigator

Alliance for Clinical Trials in Oncology

Eligibility Criteria

This trial is for patients with stage IB-IIIA non-small cell lung cancer that's been surgically removed. They must have specific EGFR mutations, be fully recovered from surgery, and not pregnant or breastfeeding. No recent chemo or radiotherapy allowed, and they should have good organ function and no history of certain eye abnormalities.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer does not have the T790M mutation in the EGFR gene.

My lung cancer was surgically removed, it was stage IB (>= 4 cm), II or IIIA, and I didn't receive chemo or radiotherapy before surgery.

Treatment Details

Interventions

• Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor)

Trial Overview The study compares the effectiveness of Erlotinib Hydrochloride (a drug blocking enzymes needed for tumor growth) against a placebo in patients after surgery. It aims to see if this treatment can prevent cancer from returning.

Participant Groups

Group I: Arm C (unblinded erlotinib hydrochloride) Experimental Treatment 2 Interventions

Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (blinded erlotinib hydrochloride) Experimental Treatment 2 Interventions

Blinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)

Group III: Arm D (observation) Active Control 2 Interventions

Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.

Group IV: Arm B (placebo) Placebo Group 2 Interventions

Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School