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Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

NCT ID: NCT01836341

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Keywords

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Afatinib Cisplatin Carboplatin Pemetrexed Radiation therapy EGFR mutation 12-279

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afatinib w Cisplatin Pemetrexed Chemoradiation

induction afatinib 40mg daily x 28days Cisplatin or Carboplatin (can be used if patient is not eligible for cisplatin) + Pemetrexed + 50Gy to pretreatment field boost to 60Gy to residual tumor + afatinib dose escalation\*

\*afatinib dose levels: 20mg daily, 30mg daily \& 40mg daily (3+3 design) Then adjuvant afatinib x 2 years

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Pemetrexed

Intervention Type DRUG

Radiation therapy

Intervention Type RADIATION

Interventions

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Afatinib

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Pemetrexed

Intervention Type DRUG

Radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Unresectable or inoperable, stage III or locoregional recurrence without evidence of distant, metastatic disease
* Pathologic confirmation of NSCLC at MSKCC
* Documentation of a sensitizing EGFR mutation
* Age ≥ 18 years
* No contraindication to definitive thoracic radiation therapy with concurrent chemotherapy

Adequate organ function as defined by:

* Calculated creatinine clearance≥ 45 mL/min (by Cockcroft-Gault)
* Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) and AST/ALT less than 3 x ULN
* Absolute neutrophil count greater than 1500/mm3
* Platelet count greater than 100,000/mm3
* Women of childbearing age must have a negative blood pregnancy test
* Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months there after

Exclusion Criteria

* Prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable)
* Ineligible for cisplatin or carboplatin per medical oncologist
* Ineligible for pemetrexed per medical oncologist
* Greater than minimal, exudative, or malignant pleural effusion
* Calculated creatinine clearance by Cockcroft \& Gault method ≤45 ml/min
* Unstable congestive heart failure
* Ejection fraction \<50% as assessed by MUGA or echocardiogram
* Interstitial lung disease
* Patient requiring on-going treatment with a potent inhibitor (cyclosporin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital with quinidine, ritonavir, valspodar, verapamil) or inducer of P-gp (St. John's wort or rifampin)
* Women who are breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie E. Chaft, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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12-279

Identifier Type: -

Identifier Source: org_study_id