NCT01221077 is a Phase 2 clinical trial of OSI-906 in NSCLC, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01221077?

NCT01221077 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01221077?

Interventions in NCT01221077: OSI-906, Erlotinib, Placebo.

What condition does NCT01221077 study?

NCT01221077 studies NSCLC, Non Small Cell Lung Cancer.

Is NCT01221077 still recruiting?

NCT01221077 is currently completed. Last updated 18 November 2025.

Last reviewed 2025-11-18 · How we verify

NCT01221077

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

Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Completed Phase 2 Last updated 18 November 2025

What this trial tests

Phase 2 trial testing OSI-906 in NSCLC in 88 participants. Completed in 1 September 2014.

Timeline

8 April 2011

Primary endpoint
1 March 2013

1 September 2014

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	88
Start date	8 April 2011
Primary completion	1 March 2013
Estimated completion	1 September 2014
Sites	29 locations across Hong Kong, South Korea, Canada, Thailand, Singapore, United States

Drugs / interventions tested

OSI-906 — full drug profile →
Erlotinib (erlotinib) — full drug profile →
Placebo

Conditions studied

NSCLC — all drugs for NSCLC →
Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with NSCLC or Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Insulin-like growth factor receptor signaling in tumorigenesis and drug resistance: a challenge for cancer therapy.
Hua H, Kong Q, Yin J, Zhang J, et al · · 2020 · cited 172× · PMID 32493414 · DOI 10.1186/s13045-020-00904-3
Molecular pathways and therapeutic targets in lung cancer.
Shtivelman E, Hensing T, Simon GR, Dennis PA, et al · · 2014 · cited 150× · PMID 24722523 · DOI 10.18632/oncotarget.1891
Molecular Pathways: Clinical Applications and Future Direction of Insulin-like Growth Factor-1 Receptor Pathway Blockade.
Iams WT, Lovly CM. · · 2015 · cited 144× · PMID 26429980 · DOI 10.1158/1078-0432.ccr-14-2518
Can we unlock the potential of IGF-1R inhibition in cancer therapy?
King H, Aleksic T, Haluska P, Macaulay VM. · · 2014 · cited 107× · PMID 25123819 · DOI 10.1016/j.ctrv.2014.07.004
Therapeutic strategies utilized in the setting of acquired resistance to EGFR tyrosine kinase inhibitors.
Yu HA, Riely GJ, Lovly CM. · · 2014 · cited 66× · PMID 25303979 · DOI 10.1158/1078-0432.ccr-13-2437
Modulation of insulin-like growth factor-1 receptor and its signaling network for the treatment of cancer: current status and future perspectives.
Jin M, Buck E, Mulvihill MJ. · · 2013 · cited 15× · PMID 25992224 · DOI 10.4081/oncol.2013.e3
Personalized medicine in metastatic non-small-cell lung cancer: promising targets and current clinical trials.
Black A, Morris D. · · 2012 · cited 10× · PMID 22787415 · DOI 10.3747/co.19.1132
Molecularly targeted therapies for advanced or metastatic non-small-cell lung carcinoma.
Bayraktar S, Rocha-Lima CM. · · 2013 · cited 7× · PMID 23696960 · DOI 10.5306/wjco.v4.i2.29

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
NCT01186861 — Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogressio · 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 recruiting trials for NSCLC

Currently open trials in the same condition.

NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
NCT07325864 — Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site · recruiting
NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting

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 NCT01221077 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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/NCT01221077.

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