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NCT01553942 · CITED IN SOURCE DOCUMENTS

Afatinib With CT and RT for EGFR-Mutant NSCLC

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2024-11-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Afatinib
    intervention Names
    1. Drug: Afatinib
    2. Radiation: Radiation
    3. Drug: Cisplatin
    4. Drug: Pemetrexed
    5. Procedure: Surgery
    label
    Afatinib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Afatinib
    description
    induction phase-two 4 week cycles. consolidation phase-twenty six 4 week cycles
    name
    Afatinib
    type
    DRUG
  2. arm Group Labels
    1. Afatinib
    description
    Daily, Monday-Friday
    name
    Radiation
    type
    RADIATION
  3. arm Group Labels
    1. Afatinib
    description
    Day 1 of each cycle, IV infusion over 60 minutes
    name
    Cisplatin
    type
    DRUG
  4. arm Group Labels
    1. Afatinib
    description
    Day 1 of each cycle, given as IV infusion over 10 minutes after cisplatin infusion
    name
    Pemetrexed
    type
    DRUG
  5. arm Group Labels
    1. Afatinib
    description
    Surgery to remove tumor
    name
    Surgery
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
19
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assess the response rate to induction afatinib.
    measure
    Response Rate
    time Frame
    2 years
secondary Outcomes
  1. description
    Estimate the 2-year progression-free survival (PFS)
    measure
    2 Year Progression-Free Survival
    time Frame
    2 years
  2. description
    Describe the number of patients that have side effects of various types from the study treatment
    measure
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    time Frame
    2 years
  3. description
    Estimate the proportion of patients with initially unresectable disease that can be converted to operable cases
    measure
    Unresectable Disease Converted to Operable Cases
    time Frame
    2 years
  4. description
    Estimate 2-year locoregional tumor control rates, distant metastasis rates and overall survival rates, as well as median overall survival (OS)
    measure
    Locoregional Tumor Control Rates
    time Frame
    2 years
  5. description
    Evaluate the status of various relevant genes such as EGFR, MET, and other genes that might be related to response or resistance to afatinib, and assess relationship to clinical outcomes
    measure
    Evaluation of EGFR Mutation Status and other genotypes
    time Frame
    2 years
Full study description
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.
detailed Description
Study treatment will be divided into 5 stages: Stage 1-induction, consisting of afatinib for two 4-week cycles. Afatinib is a pill that the patient takes by mouth once per day. The patient will receive a study drug diary in which to record the doses of afatinib. Stage 2-concurrent radiation and chemotherapy with cisplatin/pemetrexed for two 3-week cycles. Stage 3-Surgery to remove tumor for participants whose tumor can be removed by surgery. This will be done about 4-6 weeks after finishing radiation and chemotherapy. The exact timing will depend upon how quickly the patient recovers from side effects of the radiation and chemotherapy. The investigators will use a piece of the patients tumor removed by surgery for research tests to look for biomarkers such as genes and proteins that may be associated with response to afatinib, chemotherapy or radiation. Stage 4-Chemotherapy after surgery (adjuvant chemotherapy). The patients doctor will decide if the patient will receive chemotherapy after the patients surgery but before receiving consolidation with afatinib. If the patient does receive this, it will start 6-12 weeks after surgery or finishing radiation if the patient does not have surgery. The chemotherapy will be the same as that received along with the radiation therapy. Stage 5-Consolidation with afatinib for twenty-six 4-week cycles (2 years) for participants who responded to the 2 cycles of induction afatinib. The investigators would like to keep track of the patients medical condition and status of the patients disease for up to 5 years after the patient stops study treatment. Keeping in touch with the patients and checking on the patients condition every year helps the investigators look at the long-term effects of the research study. The patients will be asked to have CT scans as follows: * Every 3 months for the first year after stopping study treatment * Every 6 months for years 2-4 after stopping study treatment * Once per year in year 5 after stopping study treatment
Source references
Source notices and limitations
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        variants or <em class="gene-name">ALK</em> translocations (RTOG-1306 [<a href="/clinicaltrials/NCT01822496">NCT01822496</a>]; 11-464 [<a href="/clinicaltrials/NCT01553942">NCT01553942</a>]) (under clinical evaluation).</li><li> Adaptive radiation therapy using positron emission tomography&#8211;based response assessment during t
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        em class="gene-name">ALK</em> translocations (RTOG-1306 [<a href="/clinicaltrials/NCT01822496">NCT01822496</a>]; 11-464 [<a href="/clinicaltrials/NCT01553942">NCT01553942</a>]) (under clinical evaluation).</li><li> Adaptive radiation therapy using positron emission tomography&#8211;based response assessment during treatment (<a
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      source update dates
      1. context
        Updated: May 15, 2025
        datetime
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        display
        May 15, 2025

    Preserved source evidence · Not medical advice