Advanced Non-small Cell Lung Cancer

Oncology
14
Pipeline Programs
9
Companies
19
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
6
1
1
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
467%
Small Molecule
233%
+ 9 programs with unclassified modality

On Market (1)

Approved therapies currently available

Pfizer
LORBRENAApproved
lorlatinib
Pfizer
Kinase Inhibitor [EPC]oral2018

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
2 programs
1
1
LorlatinibPhase 4Small Molecule1 trial
PF-08634404Phase 31 trial
Active Trials
NCT07222566Recruiting1,410Est. Aug 2032
NCT04541706Completed100Est. Jul 2022
Regeneron
RegeneronTARRYTOWN, NY
3 programs
1
1
fianlimabPhase 2/3Monoclonal Antibody1 trial
BNT116Phase 21 trial
REGN2810N/A1 trial
Active Trials
NCT06269133Active Not Recruiting1,000Est. Jun 2027
NCT05557591Active Not Recruiting51Est. May 2028
NCT05785767Active Not Recruiting850Est. Feb 2032
GS
Gilead SciencesFOSTER CITY, CA
2 programs
2
DomvanalimabPhase 2Monoclonal Antibody
DomvanalimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT05676931Active Not Recruiting400Est. Dec 2027
Taiho Oncology
Taiho OncologyNJ - Princeton
2 programs
2
S-1Phase 21 trial
S-1Phase 21 trial
Active Trials
NCT00652561Completed57Est. Nov 2007
NCT00651833Completed60Est. Jul 2007
Arcus Biosciences
1 program
1
DomvanalimabPhase 2Monoclonal Antibody
Novartis
NovartisBASEL, Switzerland
1 program
1
EGF816Phase 1/21 trial
Active Trials
NCT02108964Completed225Est. Aug 2023
Bayer
BayerLEVERKUSEN, Germany
2 programs
1
BAY2927088Phase 15 trials
SevabertinibN/ASmall Molecule2 trials
Active Trials
NCT06761976Available
NCT07102095Completed18Est. Dec 2025
NCT06452277Recruiting278Est. Jun 2029
+4 more trials
CP
Chugai PharmaJapan - Tokyo
1 program
1
RO5126766Phase 11 trial
Active Trials
NCT03681483Completed15Est. Jul 2024
CT
1 program
1
TQB2928 injection + Almonertinib Mesilate TabletsPhase 11 trial
Active Trials
NCT06585059Not Yet RecruitingEst. Dec 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
PfizerLorlatinib
PfizerPF-08634404
BayerBAY2927088
Regeneronfianlimab
RegeneronBNT116
Gilead SciencesDomvanalimab
Taiho OncologyS-1
Taiho OncologyS-1
BayerBAY2927088
NovartisEGF816
BayerSevabertinib
Chia Tai TianQing Pharmaceutical GroupTQB2928 injection + Almonertinib Mesilate Tablets
BayerBAY2927088
BayerBAY2927088
BayerBAY2927088

Showing 15 of 18 trials with date data

Clinical Trials (19)

Total enrollment: 4,908 patients across 19 trials

NCT04541706PfizerLorlatinib

Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India

Start: Aug 2020Est. completion: Jul 2022100 patients
Phase 4Completed
NCT07222566PfizerPF-08634404

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Start: Jan 2026Est. completion: Aug 20321,410 patients
Phase 3Recruiting
NCT06452277BayerBAY2927088

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Start: Aug 2024Est. completion: Jun 2029278 patients
Phase 3Recruiting
NCT05785767Regeneronfianlimab

A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Start: Jun 2023Est. completion: Feb 2032850 patients
Phase 2/3Active Not Recruiting
NCT05557591RegeneronBNT116

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Start: Apr 2023Est. completion: May 202851 patients
Phase 2Active Not Recruiting
NCT05676931Gilead SciencesDomvanalimab

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Start: Feb 2023Est. completion: Dec 2027400 patients
Phase 2Active Not Recruiting
NCT00652561Taiho OncologyS-1

Phase 2 Study of S-1 as 2nd Line Therapy in Advanced Non-Small Cell Lung Cancer

Start: Feb 2005Est. completion: Nov 200757 patients
Phase 2Completed
NCT00651833Taiho OncologyS-1

Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung Cancer

Start: Feb 2005Est. completion: Jul 200760 patients
Phase 2Completed
NCT05099172BayerBAY2927088

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

Start: Oct 2021Est. completion: Dec 2026370 patients
Phase 1/2Active Not Recruiting
NCT02108964NovartisEGF816

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

Start: Jun 2014Est. completion: Aug 2023225 patients
Phase 1/2Completed
NCT07102095BayerSevabertinib

A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose

Start: Jul 2025Est. completion: Dec 202518 patients
Phase 1Completed
NCT06585059Chia Tai TianQing Pharmaceutical GroupTQB2928 injection + Almonertinib Mesilate Tablets

Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers

Start: Sep 2024Est. completion: Dec 2026
Phase 1Not Yet Recruiting
NCT06360211BayerBAY2927088

A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants

Start: Apr 2024Est. completion: Jun 202415 patients
Phase 1Completed
NCT06348888BayerBAY2927088

A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants

Start: Apr 2024Est. completion: Jun 202430 patients
Phase 1Completed
NCT06378658BayerBAY2927088

A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants

Start: Mar 2024Est. completion: Jun 202421 patients
Phase 1Completed
NCT06221475BayerBAY2927088

A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants

Start: Jan 2024Est. completion: May 20248 patients
Phase 1Completed
NCT03681483Chugai PharmaRO5126766

RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer

Start: Oct 2018Est. completion: Jul 202415 patients
Phase 1Completed
NCT06761976BayerSevabertinib

Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

N/AAvailable
NCT06269133RegeneronREGN2810

Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients

Start: Feb 2024Est. completion: Jun 20271,000 patients
N/AActive Not Recruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 4,908 patients
9 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)