Erlotinib for Non-Small Cell Lung Cancer

Not currently recruiting at 1645 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether erlotinib hydrochloride, a targeted cancer therapy, can prevent non-small cell lung cancer from returning after surgery. The study compares the effects of erlotinib hydrochloride with patient observation to determine if the cancer recurs. Participants are divided into groups: some take the medication, some receive a placebo, and others are observed. This trial targets individuals whose lung cancer has been completely removed by surgery and who have specific gene mutations in their cancer cells. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

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.

Is there any evidence suggesting that erlotinib hydrochloride is likely to be safe for humans?

Research has shown that erlotinib hydrochloride has been tested in people with non-small cell lung cancer. In these studies, the treatment extended patients' lives and improved their quality of life. Many patients tolerated it well, and it has a good safety record.

Some studies suggest that erlotinib can extend the lives of patients who have already tried other cancer treatments. While it can cause side effects like rash and diarrhea, these are usually manageable and acceptable to many patients.

Overall, erlotinib hydrochloride has shown promising results in other situations in terms of both effectiveness and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Erlotinib hydrochloride is unique because it targets the epidermal growth factor receptor (EGFR), which plays a key role in the growth and spread of cancer cells in non-small cell lung cancer. This is different from traditional chemotherapy, which generally attacks rapidly dividing cells but can affect both cancerous and healthy cells. Researchers are excited about erlotinib because its targeted approach may lead to fewer side effects and improved outcomes for patients with specific genetic mutations in their cancer. Additionally, the option of a daily oral tablet provides a more convenient administration method compared to intravenous chemotherapy.

What evidence suggests that erlotinib hydrochloride might be an effective treatment for non-small cell lung cancer?

Studies have shown that erlotinib hydrochloride can help treat non-small cell lung cancer. Research indicates it can improve survival rates in patients, even after treatments like chemotherapy. In a large group of patients, 69% experienced disease control, meaning their tumors either shrank or did not grow. Erlotinib blocks a specific protein on cancer cells, which may help stop tumor growth. In this trial, participants may receive erlotinib hydrochloride in either a blinded or unblinded manner, or they may receive a placebo or undergo observation. These findings suggest that erlotinib can be effective in managing non-small cell lung cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Ramaswamy Govindan

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5312475/

Efficacy and safety of erlotinib in the treatment of metastatic ... Erlotinib monotherapy has shown a significant improvement in median survival, quality of life, and related symptoms in an unselected population of patients.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa050753

Erlotinib in Previously Treated Non–Small-Cell Lung Cancer Erlotinib can prolong survival in patients with non–small-cell lung cancer after first-line or second-line chemotherapy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00826449

Dasatinib and Erlotinib in Non-Small Cell Lung Cancer ... Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells. Blocking the protein may control tumor growth ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086415318098

Erlotinib in Advanced Non-small Cell Lung Cancer Results: The disease control rate was 69% in 5394 patients for whom best response data were available. Survival data were available for 6580 patients. Median ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30110016/

Survival outcomes in patients with non-small-cell lung ... The median progression-free survival (time from start of erlotinib to disease progression or death from any cause) was 3.6 months. The use of erlotinib in the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20736854/

Erlotinib in advanced non-small cell lung cancer Median progression-free and overall survival times were 3.25 months and 7.9 months, respectively. The 1-year survival rate was 37.7%. Among the 6580 patients ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)33873-4/fulltext

Comparative Efficacy and Safety of Erlotinib in Non-Small ... Analyses of data from two large pivotal trials associated erlotinib treatment with significant survival benefit in both SC and AD histology subgroups, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500211001553

Second-line erlotinib in patients with advanced non-small ... Complete response, partial response and stable disease were achieved in 25 (<1%), 368 (14%) and 1444 (54%) patients, respectively, for a disease control rate of ...