NCT01186861

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

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

1. Bypass mechanisms of resistance to receptor tyrosine kinase inhibition in lung cancer.
   Niederst MJ, Engelman JA. · · 2013 · cited 219× · PMID 24065147 · DOI 10.1126/scisignal.2004652
2. 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
3. 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
4. Randomised Phase 2 study of maintenance linsitinib (OSI-906) in combination with erlotinib compared with placebo plus erlotinib after platinum-based chemotherapy in patients with advanced non-small cell lung cancer.
   Ciuleanu TE, Ahmed S, Kim JH, Mezger J, et al · · 2017 · cited 26× · PMID 28772281 · DOI 10.1038/bjc.2017.226
5. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy.
   Gold KA, Wistuba II, Kim ES. · · 2012 · cited 25× · PMID 22461458 · DOI 10.1158/1078-0432.ccr-11-2055
6. Novel small molecule EGFR inhibitors as candidate drugs in non-small cell lung cancer.
   Berardi R, Santoni M, Morgese F, Ballatore Z, et al · · 2013 · cited 16× · PMID 23723712 · DOI 10.2147/ott.s28155
7. 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
8. The Evolving Role of Maintenance Therapy Using Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in the Management of Advanced Non-Small-Cell Lung Cancer.
   Huang CH, Powers BC. · · 2012 · cited 4× · PMID 22550402 · DOI 10.4137/cmo.s5127