CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 188 enrolled
Drug / intervention
Carboplatin +3 moredrug
Likely dose
Erlotinib dosing not specified in criteria; carboplatin and paclitaxel dosing not specifiedAI-extracted
Key inclusion· 7
  • Histologically confirmed primary lung adenocarcinoma (including variants like bronchioloalveolar or adenosquamous); pure NSCLC-NOS not eligible
  • Pathology block or unstained slides available for EGFR, K-ras, Erb-2, and B-raf sequencing; at least core biopsy required
  • Stage IIIB with cytologically documented malignant pleural or pericardial effusion OR stage IV disease
  • Chemotherapy naïve; no prior neo-adjuvant or adjuvant chemotherapy
Key exclusion· 5
  • Uncontrolled CNS metastases (radiographically unstable, symptomatic, and/or requiring corticosteroids)
  • CNS lesions must be ≥3 weeks beyond completing cranial irradiation and off corticosteroid therapy
  • Dysphagia or active gastrointestinal disease/disorder that alters motility or absorption; lack of GI tract integrity (e.g., significant gastric or small bowel resection)
  • Unable to swallow intact tablets (unless able to swallow tablets dissolved in water)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00126581
NCT00126581Phase 2Completed

A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers

National Cancer Institute (NCI)·interventional·Posted Aug 4, 2005·Updated Aug 7, 2019

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Erlotinib, and 2 other interventions for Lung Adenocarcinoma and 6 related conditions. Completed, enrolled 188 participants across 96 sites.

Detailed Summary

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2005
Enrollment StartAug 15, 2005
Primary CompletionJun 30, 2010
Study CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.9 years ago

Interventions

Carboplatindrug

Given IV

Erlotinibdrug

Given PO

Erlotinib Hydrochloridedrug

Given PO

Paclitaxeldrug

Given IV