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A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Description:

This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jamie E. Chaft, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-279

NCT ID:

NCT01836341

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Afatinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Radiation therapy
  • EGFR mutation
  • 12-279
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York