Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Plain English Summary

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) is a Phase 3 clinical trial sponsored by National Cancer Institute (NCI) studying 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. Tests if erlotinib can improve survival in patients with resected EGFR mutant NSCLC. For patients who have had their lung cancer completely removed by surgery and have EGFR mutations. Participation involves taking erlotinib or observation and regular check-ups. No other treatments are needed, but regular follow-ups are required. The trial aims to enroll 390 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if previously registered to A151216 with EGFR exon 19 deletion or L858R mutation. Not eligible if resistant to EGFR TK domain mutations or has ALK rearrangements. Age ≥ 18, ECOG PS 0-1, no locally advanced or metastatic cancer, no pregnancy or lactation. No history of cornea abnormalities, normal blood tests. This trial is studying 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, so participants generally need a confirmed diagnosis.

What They're Measuring

Measures overall survival, helping patients understand the long-term impact of the treatment. The specific primary outcome measures are: Overall survival (OS) (The time from randomization until death, assessed up to 10 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill the gap in treatment options for patients with resected EGFR mutant NSCLC. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets 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, where improved treatment options are needed.

Investor Insight

Significant market size, competitive landscape, high approval probability given the unmet need. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you have an EGFR mutation and if you are a candidate for this trial. Participation involves regular check-ups and taking a pill daily. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 390 participants

Interventions

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

Primary Outcomes

• Overall survival (OS) (The time from randomization until death, assessed up to 10 years)

Secondary Outcomes

• Disease free survival (DFS) rate (Time from randomization until documented disease-recurrence or death, whichever occurs first, assessed at 2 years)
• Overall survival (OS) rate at 5 years (At 5 years)
• Overall survival (OS) rate at 10 years (At 10 years)
• Overall disease free survival (DFS) between the erlotinib hydrochloride and observation arms (Time from randomization until documented disease-recurrence or death, whichever occurs first, assessed up to 10 years)
• Incidence of adverse events associated with each treatment arm (Up to 10 years)

Full Eligibility Criteria

Inclusion Criteria:

* Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:

  1. Patient registered to A151216 and the assessment performed centrally by the protocol-specified laboratory
  2. By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results

     * Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible
     * Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
* Completely resected stage IB (\>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
* Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration
* Non-pregnant and non-lactating
* No history of cornea abnormalities
* Granulocytes \>= 1,500/ul
* Platelets \>= 100,000/ul
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 1.5 x ULN
* Serum creatinine =\< 1.5 x ULN

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Southern Cancer Center PC-Daphne, Daphne, Alabama, United States
• Southern Cancer Center PC-Mobile, Mobile, Alabama, United States
• Southern Cancer Center PC-Providence, Mobile, Alabama, United States
• Southern Cancer Center PC-Springhill, Mobile, Alabama, United States
• Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
• Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
• Alaska Regional Hospital, Anchorage, Alaska, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• EGFR mutant non-small cell lung cancer
• Lung cancer
• Non-small cell lung cancer
• Stage IB-IIIA NSCLC
• Lung cancer surgery
• EGFR mutation testing
• Adjuvant therapy
• Disease-free survival

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