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

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ClinicalTrials.gov Identifier: NCT01836341
Recruitment Status : Withdrawn
First Posted : April 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborators:
Boehringer Ingelheim
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Afatinib Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Radiation: Radiation therapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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

 Drug: Afatinib
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Radiation: Radiation therapy


Outcome Measures
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Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 1 year ]
    This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.


Secondary Outcome Measures :
  1. local control rate [ Time Frame: at 1 year and at 2 years ]
    will be determined as the proportion of patients who start the concurrent phase who are alive and free of local failure.

  2. tolerability of adjuvant afatinib [ Time Frame: at 3 months ]
    Tolerability will be defined by in terms of dose reductions, delays and discontinuations of patients who have not had disease progression or death.

  3. median progression free survival [ Time Frame: 2 years ]
    PFS is defined as the duration of time from start of treatment to time of progression of disease or death, whichever occurs first.

  4. median overall survival [ Time Frame: 2 years ]
    will be calculated using Kaplan-Meier estimates among all patients enrolled.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836341


Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Boehringer Ingelheim
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Jamie E. Chaft, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01836341    
Other Study ID Numbers: 12-279
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
Afatinib
Cisplatin
Carboplatin
Pemetrexed
 Radiation therapy
EGFR mutation
12-279
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Carboplatin
 Pemetrexed
Afatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors