Erlotinib for Non-Small Cell Lung Cancer

Recruiting at 1601 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Metastatic cancer, Secondary lung cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 33

Duration: 2 years

450 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Erlotinib Hydrochloride for treating non-small cell lung cancer?

Erlotinib is effective for non-small cell lung cancer with specific genetic changes (EGFR mutations), and its effectiveness has been shown in several trials. It has also been used successfully in cases where other treatments failed, even in patients without these genetic changes. ^{1 2 3 4 5}

Is erlotinib generally safe for humans?

Erlotinib is generally considered safe for humans, but it can cause side effects like interstitial lung disease (a lung condition) and other manageable adverse events. Some severe side effects may require reducing the dose or stopping the treatment. ^{6 7 8 9 10}

How is the drug Erlotinib different from other treatments for non-small cell lung cancer?

Erlotinib is unique because it is an oral drug that specifically targets and inhibits the epidermal growth factor receptor (EGFR), which is often overactive in non-small cell lung cancer. This targeted approach can be more effective for patients with specific EGFR mutations compared to traditional chemotherapy. ^{1 4 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive erlotinib hydrochloride or placebo orally once daily for 21-day cycles, repeated for up to 2 years

2 years

Every 21 days

Observation

Participants undergo observation at least every 6 months for 2 years

2 years

Every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 6 months for 4 years, then yearly for 6 years

Treatment Details

Interventions

• Erlotinib Hydrochloride

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+

Findings from Research

Erlotinib, a drug that targets the epidermal growth factor receptor (EGFR), was well tolerated in a study involving four adult rhesus monkeys, showing a mean terminal half-life of 5.2 hours after intravenous administration.

Both erlotinib and its active metabolite OSI-420 were detectable in cerebrospinal fluid (CSF), but their penetration was limited to less than 5% of total plasma concentrations, although CSF exposure was about 30% of the free drug exposure in plasma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in non-human primates. Meany, HJ., Fox, E., McCully, C., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics of Erlotinib in Patients With Non-small Cell Lung Cancer: Its Application for Individualized Dosing Regimens in Older Patients. [2021]

2. Greece pubmed.ncbi.nlm.nih.gov

Serious hematologic complications following erlotinib treatment. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Erlotinib-induced complete response in a patient with epidermal growth factor receptor wild-type lung adenocarcinoma after chemotherapy failure: a case report. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in non-human primates. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Classical versus non-classical EGFR mutations: Erlotinib response and impact of renal insufficiency. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Efficacy of erlotinib on advanced non-small cell lung cancer]. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Erlotnib in the treatment of advanced non-small cell lung cancer failed to previous chemotherapy]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors for the treatment of rapidly progressing refractory corneal melting due to erlotinib in nonsmall cell lung cancer. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

New-onset acute interstitial lung disease after treatment with erlotinib in a patient with metastatic squamous cell carcinoma of the lung. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

A phase I study of the tyrosine kinase inhibitor anlotinib combined with platinum/pemetrexed-based chemotherapy in untreated nonsquamous non-small-cell lung cancer. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Icotinib is an active treatment of non-small-cell lung cancer: a retrospective study. [2021]

13. China pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on Anlotinib Hydrochloride for advanced lung cancer (2020 edition)]. [2021]