Non-Small-Cell Lung Carcinoma

Oncology
14
Pipeline Programs
12
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
9
1
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 12 programs with unclassified modality

On Market (1)

Approved therapies currently available

AstraZeneca
IRESSAApproved
gefitinib
AstraZeneca
oral2003

Competitive Landscape

11 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
1
1
GefitinibPhase 3Small Molecule5 trials
AZD2936Phase 1/21 trial
Active Trials
NCT04995523Recruiting210Est. Mar 2028
NCT00268255Withdrawn0
NCT00683306Approved For Marketing
+3 more trials
Transgene
TransgeneFrance - Illkirch-Graffenstaden
1 program
1
TG4010Phase 2/31 trial
Active Trials
NCT01383148TerminatedEst. Jul 2016
Pfizer
PfizerNEW YORK, NY
2 programs
1
EKB-569Phase 21 trial
AlectinibN/ASmall Molecule1 trial
Active Trials
NCT04351334Completed161Est. Nov 2022
NCT00067548Completed44Est. Jan 2005
Genentech
GenentechCA - Oceanside
2 programs
2
AvastinPhase 21 trial
OSI-774Phase 21 trial
Active Trials
NCT00095225Completed122Est. Nov 2006
NCT00137800Completed82Est. Mar 2007
Bristol Myers Squibb
1 program
1
BMS-690514Phase 25 trials
Active Trials
NCT01167244Completed11Est. Apr 2011
NCT01068704Completed4Est. Dec 2010
NCT00743938Completed141Est. Jun 2012
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
Cetuximab + platinum + gemcitabinePhase 21 trial
Active Trials
NCT00112346Completed120Est. Dec 2006
E
EisaiChina - Liaoning
1 program
1
E7389 28 Day CyclePhase 21 trial
Active Trials
NCT00100932Completed106
Providence Therapeutics
1 program
1
Neoadjuvant Therapy with Cisplatin Plus DocetaxelPhase 2
Novartis
NovartisBASEL, Switzerland
1 program
1
RAD001Phase 21 trial
Active Trials
NCT00124280Completed85
Sanofi
SanofiPARIS, France
1 program
1
docetaxel and cisplatinPhase 21 trial
Active Trials
NCT00271323Terminated14Est. Feb 2007
AB
Active BiotechSweden - Lund
1 program
1
ABR-217620Phase 11 trial
Active Trials
NCT00056537CompletedEst. Dec 2006

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib
AstraZenecaGefitinib

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 9,769 patients across 50 trials

Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC

Start: Dec 2014Est. completion: Oct 201761 patients
Phase 4Terminated

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Start: Sep 2010Est. completion: Jun 20161,060 patients
Phase 4Completed

Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)

Start: Sep 2008Est. completion: Feb 2011296 patients
Phase 4Completed

Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Start: Oct 2007Est. completion: Aug 200914 patients
Phase 4Terminated

SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

Start: Jan 2007Est. completion: Jan 2009156 patients
Phase 4Completed

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Start: Dec 2014Est. completion: Nov 2025674 patients
Phase 3Completed

A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

Start: Mar 2012Est. completion: Nov 2019265 patients
Phase 3Completed

First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

Start: Oct 2005Est. completion: Mar 2010315 patients
Phase 3Completed

Iressa as Second Line Therapy in Advanced NSCLC-Asia

Start: Sep 2005Est. completion: Feb 2009163 patients
Phase 3Completed

Iressa Follow-up Trial

Start: Jan 2005Est. completion: May 201514 patients
Phase 3Completed

Iressa Versus Docetaxel (Taxotere)

Start: Feb 2004Est. completion: Oct 20071,440 patients
Phase 3Completed

Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

Start: Nov 2003Est. completion: Sep 2007477 patients
Phase 3Completed

Iressa 2nd Line Phase III Study in Japan

Start: Sep 2003Est. completion: Nov 2006484 patients
Phase 3Completed

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

Start: Jul 2003Est. completion: Apr 20051,692 patients
Phase 3Completed

Iressa Expanded Access Program (EAP)

Start: Aug 2000Est. completion: Oct 2003
Phase 3Completed

ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Start: May 2000
Phase 3Unknown

Open-Label Extension of Other SZ1839 (Iressa) Trials

Start: Feb 2000Est. completion: Oct 2003100 patients
Phase 3Completed

Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB

Start: Nov 2015Est. completion: Jan 20181 patients
Phase 2/3Terminated

Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer

Start: Apr 2012Est. completion: Jul 2016
Phase 2/3Terminated

Iressa v BSC (Best Supportive Care) in First Line NSCLC

Start: Sep 2004Est. completion: Apr 2016216 patients
Phase 2/3Completed

A Phase 2 Study of Tomudex & Iressa as Second Line Chemotherapy in Subjects With Colorectal Carcinoma

Start: Nov 2003Est. completion: Jun 200674 patients
Phase 2/3Completed

Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

Est. completion: Jan 200544 patients
Phase 2Completed

Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment

Start: Jul 2012Est. completion: Jul 201461 patients
Phase 2Completed

First Line Gefitinib by FDG-PET Metabolic Response

Start: Apr 2012Est. completion: Nov 201560 patients
Phase 2Unknown

Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

Start: Mar 2012Est. completion: Feb 2015162 patients
Phase 2Unknown

Feasibility Study to Estimate Number of Patients With Precancerous Areas in Their Airways and the Response to Gefitinib

Start: Dec 2011Est. completion: Jun 201632 patients
Phase 2Terminated

Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response

Start: Aug 2010Est. completion: Apr 201111 patients
Phase 2Completed

Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Start: Jun 2010Est. completion: Dec 20104 patients
Phase 2Completed

A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

Start: Mar 2009Est. completion: Jun 2012141 patients
Phase 2Completed

Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)

Start: Jan 2009Est. completion: Dec 201123 patients
Phase 2Completed

First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Start: Mar 2006Est. completion: Dec 200746 patients
Phase 2Completed

Adjuvant Therapy of Gefitinib (Iressa, ZD1839) in Patients With Resectable Hepatocellular Carcinoma

Start: Dec 2005Est. completion: Sep 201940 patients
Phase 2Unknown

Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

Start: Sep 2005Est. completion: Jul 201154 patients
Phase 2Terminated

Therapy for Children With Neuroblastoma

Start: Aug 2005Est. completion: Jun 200723 patients
Phase 2Completed

Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Start: Jul 200585 patients
Phase 2Completed
NCT00271323Sanofidocetaxel and cisplatin

Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients

Start: May 2005Est. completion: Feb 200714 patients
Phase 2Terminated

Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Start: Apr 2005Est. completion: Dec 200990 patients
Phase 2Completed

Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

Start: Mar 2005Est. completion: May 201344 patients
Phase 2Completed

Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC

Start: Jan 2005Est. completion: Nov 200935 patients
Phase 2Completed
NCT00112346Eli Lilly and CompanyCetuximab + platinum + gemcitabine

Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Start: Jan 2005Est. completion: Dec 2006120 patients
Phase 2Completed
NCT00100932EisaiE7389 28 Day Cycle

Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy

Start: Dec 2004106 patients
Phase 2Completed

IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma

Start: Nov 2004Est. completion: Jun 2008224 patients
Phase 2Completed

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

Start: Nov 2004Est. completion: Dec 2008126 patients
Phase 2Completed

Phase II Iressa & Carbo/Gem in NSCLC

Start: Oct 2004Est. completion: Jun 200838 patients
Phase 2Completed

Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

Start: Oct 2004Est. completion: May 2007160 patients
Phase 2Completed

Phase II Iressa + Irradiation Followed by Chemo in NSCLC

Start: Sep 2004Est. completion: Jan 200650 patients
Phase 2Completed

Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma

Start: Sep 2004Est. completion: Dec 200645 patients
Phase 2Completed

Phase II Iressa Versus Vinorelbine (INVITE)

Start: Jul 2004Est. completion: Feb 2006192 patients
Phase 2Completed

Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Start: Jul 2004Est. completion: Jan 2006190 patients
Phase 2Withdrawn

Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

Start: Jul 2004Est. completion: Feb 200647 patients
Phase 2Terminated

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
12 companies competing in this space