Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

Conditions

• Lung Non-Squamous Non-Small Cell Carcinoma
• Stage IB Lung Non-Small Cell Carcinoma AJCC v7
• Stage II Lung Non-Small Cell Cancer AJCC v7
• Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clinical Observation — OTHER
  Undergo observation
• Erlotinib Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Placebo Administration — OTHER
  Given PO

Study Details

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.

Key Dates

First listed

Jul 17, 2014

Start date

Feb 11, 2015

Status verified

Feb 2026

Primary completion

Dec 6, 2025

Completion

Feb 3, 2027

Study Design

Enrollment

390 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (blinded erlotinib hydrochloride)
  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)
• Placebo Comparator: Arm B (placebo)
  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)
• Experimental: Arm C (unblinded erlotinib hydrochloride)
  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.
• Active Comparator: Arm D (observation)
  Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: The time from randomization until death, assessed up to 10 years ]

Locations (1403)