Afatinib With CT and RT for EGFR-Mutant NSCLC

NCT01553942 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 11-464
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that study doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved the drug for the patients type of cancer or for any use outside of research studies. Chemotherapy and radiation is the standard treatment for the patients with stage III non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR) mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase the response to treatment. Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in participants with more advanced NSCLC. Results from that study indicate it may be helpful in treating NSCLC with EGFR mutations. In this study, patients with stage III NSCLC and EGFR mutations will receive the standard treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the radiation therapy more effective since radiation therapy tends to work better on smaller tumors. The goal of this study is to see if adding afatinib to standard treatment helps to improve the response to treatment.

Conditions

Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Assess the response rate to induction afatinib.

  2 years

Secondary Outcomes (5)

• 2 Year Progression-Free Survival

  2 years

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2 years

• Unresectable Disease Converted to Operable Cases

  2 years

• Locoregional Tumor Control Rates

  2 years

• Evaluation of EGFR Mutation Status and other genotypes

  2 years

Study Arms (1)

Afatinib

EXPERIMENTAL

Afatinib

Drug: Afatinib; Radiation: Radiation; Drug: Cisplatin; Drug: Pemetrexed; Procedure: Surgery

Interventions

Afatinib DRUG

induction phase-two 4 week cycles. consolidation phase-twenty six 4 week cycles

Afatinib

Radiation RADIATION

Daily, Monday-Friday

Afatinib

Cisplatin DRUG

Day 1 of each cycle, IV infusion over 60 minutes

Afatinib

Pemetrexed DRUG

Day 1 of each cycle, given as IV infusion over 10 minutes after cisplatin infusion

Afatinib

Surgery PROCEDURE

Surgery to remove tumor

Afatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed stage IIIA NSCLC
• Measurable disease
• Have lung cancer harboring an EGFR mutation
• Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon within 4 weeks of enrollment into study to document that they are a candidate for chemoradiation and for consideration of surgical resection (not required to be a surgical candidate)

You may not qualify if:

• Pregnant or breastfeeding
• Prior EGFR TKI therapy
• Prior treatment with radiation to the thoracic region (including breast irradiation)
• Known pre-existing interstitial lung disease
• Significant or recent gastrointestinal disorders with diarrhea as a major symptom
• History or presence of relevant cardiovascular abnormalities
• Any other concomitant serious illness or organ system dysfunction
• Active hepatitis B, C or known HIV carrier
• Known or suspected active drug or alcohol use
• Known hypersensitivity to afatinib, cisplatin, or pemetrexed
• Concomitant treatment with strong inhibitor of P-gp
• History of an active malignancy within the last 3 years

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Afatinib; Radiation; Cisplatin; Pemetrexed; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Physical Phenomena; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Lecia V Sequist, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 14, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (2)