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A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)

- Erlotinib is a pill taken daily and participants may continue to receive erlotinib for
up to two years, as long as the cancer does not return and they do not experience any
unacceptable side effects.

- While participants are receiving erlotinib, they will be asked to return to the clinic
for study visits to monitor the status of their disease and their general health. For
the first 5 months of erlotinib, they will return to the clinic monthly. After that
they will return to the clinic every three months.

Inclusion Criteria:

- Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology

- Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition
staging criteria

- Patients must have undergone surgical resection with curative intent within 6 months
of enrollment

- Sufficient tumor tissue available for EGFR mutation analysis

- At least ONE of the following patient characteristics: previously detected deletion
19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim
ethnicity (to be enrolled in the screening portion of trial).

- 18 years of age or older

- Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point

- ECOG Performance status of 0,1, or 2

- Adequate organ function as outlined in protocol

Exclusion Criteria:

- Radiographic evidence of recurrent NSCLC prior to erlotinib treatment

- Confirmed T790M resistance mutation in the primary tumor sample

- Prior exposure to EGFR tyrosine kinase inhibitors

- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug

- Pregnant or breastfeeding women

- Any evidence of clinically active interstitial lung disease

- Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine,
oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study

- Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto
the trial, or failure to recover from the side effects of any of these agents

Type of Study:


Study Design:

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

Outcome Measure:

To determine the 2-year disease-free survival of patients with resected, early stage NSCLC who have activating mutations in the EGFR gene, after treatment with adjuvant erlotinib.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia V. Sequist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2007

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • erlotinib
  • epidermal growth factor receptor
  • EGFR
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Stanford University Stanford, California  94305
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hosptial Boston, Massachusetts  02114
North Shore Medical Center Salem, Massachusetts  01970
Taussig Cancer Center Cleveland, Ohio  44195