NSCLC Clinical Trials Assessment 2025: Therapeutics Landscape, FDA Approvals, Pipeline Analysis, Competitive Landscape, Therapies, Medication, ROA, MOA by DelveInsight

NSCLC Clinical Trials Assessment

Non-Small Cell Lung Cancer Clinical Trial Summary

The NSCLC pipeline is highly active, with 135+ companies developing 150+ therapies. Key players include Daiichi Sankyo, Merck, Pfizer/AbbVie, Eli Lilly, BioNTech, Bristol Myers Squibb, Bayer, and Innovent Biologics. Promising candidates include trastuzumab deruxtecan, DS-1062a, pembrolizumab, domvanalimab, zimberelimab, cemiplimab, osimertinib, and others. Recent updates highlight FDA designations and trial progress: Boan Biotechnology’s BA1302 received ODD (March 2025); CERo gained IND clearance for CER-1236 (March 2025); Dizal’s Sunvozertinib received priority review (Jan 2025); and Nuvation Bio’s taletrectinib NDA was accepted (Dec 2024). Major studies by Merck, AstraZeneca, and Gilead are advancing combination therapies to improve outcomes in early and metastatic NSCLC.

DelveInsight’s, “Non-Small-Cell Lung Cancer Pipeline Insight 2025” report provides comprehensive insights about 135+ NSCLC Companies and 150+ pipeline drugs in the Non-Small-Cell Lung cancer (NSCLC) pipeline landscape. It covers the NSCLC pipeline drug profiles, including clinical and nonclinical stage products. It also covers the NSCLC pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay Ahead in the NSCLC Landscape – Explore detailed profiles of 135+ companies, 150+ pipeline therapies, trial updates, and emerging treatment strategies. Access the full NSCLC Clinical Trial Report

Key Takeaways from the NSCLC Pipeline Report

• DelveInsight’s NSCLC pipeline report depicts a robust space with 135+ active players working to develop 150+ pipeline therapies for NSCLC treatment.
• The leading NSCLC Companies working in the market include BridgeBio Pharma, Daiichi Sankyo, EMD Serono/Merck, BridgeBio Pharma, Abbvie/Pfizer, Eli Lilly and Company, BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical/Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, and others.
• Promising NSCLC Pipeline Therapies in the various stages of development include Trastuzumab deruxtecan, DS-1062a, Docetaxel, Pembrolizumab (MK-3475) 200 mg, Domvanalimab, Zimberelimab, Quemliclustat, BNT116, Cemiplimab, SKB264, Carboplatin, Osimertinib, and others.
• In March 2025, Boan Biotechnology (06955.HK) announced that its CD228-targeting antibody-drug conjugate, BA1302, had been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of squamous non-small cell lung cancer and pancreatic cancer.
• In March 2025, CERo Therapeutics Holdings, Inc. reported that the FDA had cleared its second Investigational New Drug (IND) application for its lead candidate, CER-1236, enabling the company to initiate a Phase 1 clinical trial in patients with advanced solid tumors, including non-small cell lung cancer and ovarian cancer.
• In January 2025, the FDA granted priority review to Dizal’s new drug application (NDA) for Sunvozertinib, intended for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
• In December 2024, Nuvation Bio Inc., a global oncology-focused biopharmaceutical company, announced that the FDA had accepted its NDA submission for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) being developed for the treatment of advanced ROS1-positive NSCLC, regardless of prior treatment history.
• December 2023: Merck Sharp & Dohme LLC announced a study of Phase 3 clinical trials for V940 and Pembrolizumab. The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) NSCLC. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
• December 2023: AstraZeneca announced a study of Phase 2 clinical trials for Durvalumab, Oleclumab, Monalizumab, MEDI5752, and AZD0171. The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy; or MEDI5752 in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage NSCLC.
• December 2023: Gilead Sciences announced a study of Phase 3 clinical trials for Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, and Cisplatin. The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic NSCLC with no actionable genomic alteration.

Request a sample and discover the recent advances in NSCLC Treatment Drugs @ NSCLC Pipeline Outlook Report

NSCLC Overview

NSCLC (Non-Small Cell Lung Cancer) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases globally. NSCLC typically grows and spreads more slowly than small cell lung cancer, offering a broader window for treatment interventions. NSCLC symptoms often include persistent coughing, chest pain, shortness of breath, and unexplained weight loss. NSCLC diagnosis usually involves imaging tests such as CT scans, biopsies, and molecular profiling to determine genetic mutations. NSCLC staging ranges from localized Stage I to advanced metastatic Stage IV, significantly impacting treatment decisions.

NSCLC treatment options include surgery, radiation therapy, chemotherapy, targeted therapies, and emerging immunotherapies. NSCLC targeted therapies focus on specific mutations like EGFR, ALK, and ROS1, offering personalized treatment approaches. NSCLC immunotherapy has transformed patient outcomes by harnessing the body’s immune system to fight cancer cells. NSCLC clinical trials continue to explore innovative drugs and combination therapies to improve survival rates.

NSCLC prognosis varies based on stage, patient health, and genetic factors, with early detection being crucial for better outcomes. NSCLC research and development are rapidly evolving, bringing hope for more effective therapies. As awareness and advanced treatments grow, the NSCLC landscape continues to change, improving patient care worldwide.

Find out more about NSCLC Treatment Landscape @ Drugs for NSCLC Treatment

NSCLC Emerging Drugs Profile

V940 (Merck Sharp & Dohme LLC) V940 is an mRNA-based personalized cancer vaccine designed to trigger T-cell responses using up to 34 neoantigens derived from a patient’s tumor mutations. It is currently in Phase III trials for NSCLC.

QL1706 (Qilu Pharmaceutical Co., Ltd.) QL1706 is a bifunctional antibody combining PD-1 and CTLA-4 blockade to enhance anti-tumor activity. It is in Phase III development for NSCLC.

Zenocutuzumab (MCLA-128; Merus N.V.) Zeno is a bispecific antibody that blocks HER3/NRG1 fusion signaling by binding HER2 and preventing HER2-HER3 interaction, thereby inhibiting tumor growth. It is in Phase II for NSCLC.

ZW49 (Zymeworks BC Inc.) ZW49 (zanidatamab zovodotin) is a bispecific HER2-targeted antibody-drug conjugate based on ZW25, delivering a cytotoxic payload while blocking HER2 signaling. It is in Phase I trials for NSCLC.

NSCLC Pipeline Therapeutics Assessment

There are approx. 135+ key NSCLC companies which are developing the NSCLC therapies. The NSCLC companies which have their Non-Small-Cell Lung cancer (NSCLC) drug candidates in the most advanced stage, i.e. Phase III include Daiichi Sankyo.

DelveInsight’s NSCLC Pipeline report covers around 150+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Non-Small-Cell Lung cancer ROA

Non-Small-Cell Lung cancer Pipeline Report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Subcutaneous
• Intravenous
• Oral
• Parenteral
• Intramuscular

NSCLC Products have been categorized under various Molecule types such as

• Small molecules
• Peptides
• Polymer
• Gene Therapy
• Monoclonal antibodies

Learn more about the emerging NSCLC Pipeline Therapies @ NSCLC Clinical Trials Assessment

Non-Small Cell Lung Cancer Market Drivers

• High Disease Burden: NSCLC accounts for ~85% of all lung cancers, ensuring strong demand for therapies.
• Advances in Targeted Therapies: Growth driven by EGFR, ALK, ROS1, KRAS, and PD-1/PD-L1 inhibitors, expanding precision medicine options.
• Immunotherapy Expansion: Drugs like pembrolizumab, cemiplimab, and durvalumab have revolutionized treatment with survival benefits.
• Strong R&D Pipeline: 150+ therapies in development with innovative mechanisms (FcRn inhibitors, antibody-drug conjugates, next-gen TKIs).
• Regulatory Support: Multiple FDA designations (priority reviews, orphan drug, breakthrough therapy) accelerate drug development.
• Growing Diagnostic Advancements: Improved biomarker testing (PD-L1, NGS panels) supports early detection and patient stratification.

Non-Small Cell Lung Cancer Market Barriers

• High Treatment Costs: Targeted therapies and immunotherapies impose significant financial burden on patients and healthcare systems.
• Drug Resistance: Many patients develop resistance to EGFR, ALK, and KRAS inhibitors, limiting long-term efficacy.
• Heterogeneity of NSCLC: Genetic and molecular diversity complicates treatment personalization.
• Access and Affordability Gaps: Limited access to advanced therapies in low- and middle-income countries restricts global adoption.
• Adverse Effects: Immunotherapy-related toxicities and long-term safety concerns affect compliance and quality of life.
• Clinical Trial Challenges: Complex trial designs, recruitment issues, and stringent regulatory hurdles slow development timelines.

Scope of the Non-Small Cell Lung Cancer Pipeline Report

• Coverage- Global
• NSCLC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• NSCLC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• NSCLC Companies- BridgeBio Pharma (NASDAQ: BBIO), Daiichi Sankyo (TYO: 4568), EMD Serono/Merck (FWB: MRK), AbbVie (NYSE: ABBV)/Pfizer (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), BioNTech SE (NASDAQ: BNTX), Shenzhen TargetRx (Private), Taiho Pharmaceutical (Private), Chong Kun Dang (KRX: 185750), Bristol Myers Squibb (NYSE: BMY), Innovent Biologics (HKEX: 01801), Xuanzhu Biopharmaceutical (Private), Bayer (FWB: BAYN), GeneScience Pharmaceuticals (Private), InventisBio (SHA: 688382), Apollomics (NASDAQ: APLM), Imugene (ASX: IMU), Ono Pharmaceutical (TYO: 4528)/Pierre Fabre (Private), Jiangsu Hengrui Medicine Co. (SHA: 600276), Surface Oncology (acquired by Coherus BioSciences, NASDAQ: CHRS), Inhibrx (NASDAQ: INBX), Sinocelltech (SHA: 688520), Mirati Therapeutics (NASDAQ: MRTX), REVOLUTION Medicines (NASDAQ: RVMD), Yong Shun Technology Development (Private), Iovance Biotherapeutics (NASDAQ: IOVA), Galecto Biotech (NASDAQ: GLTO), and others.
• NSCLC Pipeline Therapies in the various stages of development include Trastuzumab deruxtecan, DS-1062a, Docetaxel, Pembrolizumab (MK-3475) 200 mg, Domvanalimab, Zimberelimab, Quemliclustat, BNT116, Cemiplimab, SKB264, Carboplatin, Osimertinib, and others.

Dive deep into rich insights for new drugs for NSCLC treatment, Visit @ NSCLC Market Drivers and Barriers, and Future Perspective

Table of Content

Introduction

Executive Summary

Non-Small-Cell Lung cancer (NSCLC) : Overview

• Introduction
• Causes
• Pathophysiology
• Signs and Symptoms
• Diagnosis
• Treatment

Pipeline Therapeutics

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Non-Small-Cell Lung cancer (NSCLC) – DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

• Comparative Analysis

V940: Merck Sharp & Dohme LLC

• Product Description
• Research and Development
• Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

• Comparative Analysis

Zenocutuzumab (MCLA-128): Merus N.V.

• Product Description
• Research and Development
• Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

• Comparative Analysis

ZW49: Zymeworks BC Inc.

• Product Description
• Research and Development
• Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

• Comparative Analysis

Drug name: Company name

• Product Description
• Research and Development
• Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

• Comparative Analysis

Non-Small-Cell Lung cancer (NSCLC) Key Companies

Non-Small-Cell Lung cancer (NSCLC) Key Products

Non-Small-Cell Lung cancer (NSCLC) – Unmet Needs

Non-Small-Cell Lung cancer (NSCLC) – Market Drivers and Barriers

Non-Small-Cell Lung cancer (NSCLC) – Future Perspectives and Conclusion

Non-Small-Cell Lung cancer (NSCLC) Analyst Views

Non-Small-Cell Lung cancer (NSCLC) Key Companies

Appendix

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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