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Withdrawn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
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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 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 |

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

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

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
Principal Investigator: | Jamie E. Chaft, MD | Memorial Sloan Kettering Cancer Center |
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 |
Afatinib Cisplatin Carboplatin Pemetrexed |
Radiation therapy EGFR mutation 12-279 |
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 |