Clinical Trial - NCT01553942

Afatinib With CT and RT for EGFR-Mutant NSCLC

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators:

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Lecia V. Sequist Principal Investigator

ClinicalTrials.gov Identifier: NCT01553942

Protocol Info

Short Description: Afatinib Sequenced with Concurrent CT and XRT in EGFR-Mutant NSCLC: The ASCENT Trial
Long Description: Afatinib Sequenced with Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial.
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Thoracic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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.
Condition Title Intervention Phase
Lung Cancer Afatinib Radiation Cisplatin Pemetrexed Surgery Phase 2
Study Type Interventional
Official Title Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial

Primary Outcome Measures

Response Rate [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

2 Year Progression-Free Survival [Time Frame: 2 years] [Designated as safety issue: ]

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 2 years] [Designated as safety issue: ]

Unresectable Disease Converted to Operable Cases [Time Frame: 2 years] [Designated as safety issue: ]

Locoregional Tumor Control Rates [Time Frame: 2 years] [Designated as safety issue: ]

Evaluation of EGFR Mutation Status and other genotypes [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019
Arms Assigned Interventions

Experimental:Afatinib

Afatinib
Procedure:Surgery
Surgery to remove tumor

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553942

Locations

  • United States, Massachusetts
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Massachusetts General Hospital

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Lecia V. Sequist Principal Investigator
ClinicalTrials.gov Identifier: NCT01553942
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

NSCLC

Additional relevant MeSH terms:

Cisplatin

Pemetrexed

Afatinib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019