Phase 2
N=68
TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer · Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00563784 ↗Enrolled (actual)
68
Serious AEs
21.7%
Results posted
Nov 2019
Primary outcome: Primary: Time To First Disease Progression — 14 Month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib (Drug); Carboplatin (Drug); Paclitaxel (Drug); Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time To First Disease Progression |
14 | — |
| SECONDARY Overall Survival and Disease Local Control Rate |
35.9; 25.8; 55.8; 36.5 | — |
Summary
The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control NSCLC. The safety of this combination treatment will also be studied.
Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded. ·
- Patients must be M0;
- Patients with Tl or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable. Radiographic evidence of mediastinal lymph nodes > 2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease. If the largest mediastinal node is grade 1 neuropathy;
- Evidence of malignancy in the past 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers;
- Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration;
- Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for four weeks after completion of treatment or those who are using a prohibited contraceptive method (methods with unknown efficacy).
- Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days. Clinical trials involving administration of investigational agents or interfering with the safe conduct of this trial. All clinical trials would exclude observational trials which would not interfere with the endpoints of our study.
Data sourced from ClinicalTrials.gov (NCT00563784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.