Who is sponsoring NCT01186861?

NCT01186861 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01186861?

Interventions in NCT01186861: OSI-906, erlotinib, placebo.

Is NCT01186861 still recruiting?

NCT01186861 is currently completed. Last updated 18 November 2025.

Last reviewed 2025-11-18 · How we verify

NCT01186861

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Completed Phase 2 Last updated 18 November 2025

What this trial tests

Phase 2 trial testing OSI-906 in Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy in 205 participants. Completed in 11 March 2015.

Timeline

4 March 2011

Primary endpoint
1 July 2013

11 March 2015

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	205
Start date	4 March 2011
Primary completion	1 July 2013
Estimated completion	11 March 2015
Sites	69 locations across Russia, United Kingdom, Germany, Poland, South Korea, Romania, Canada, United States

Drugs / interventions tested

OSI-906 — full drug profile →
erlotinib (erlotinib) — full drug profile →
placebo

Conditions studied

Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy — all drugs for Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of OSI-906

Trials testing the same drug.

NCT01529684 — A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body · Phase 1 · completed
NCT01221077 — Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) W · Phase 2 · completed
NCT01101906 — A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC · Phase 2 · terminated
NCT00924989 — A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma · Phase 3 · completed
NCT00889382 — A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovari · Phase 1, PHASE2 · completed

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01186861 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 18 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01186861.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing