Press release
NSCLC Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight
NSCLC Clinical Trials
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- https://www.delveinsight.com/report-store/non-small-cell-lung-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
The NSCLC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NSCLC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NSCLC clinical trial landscape.
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- https://www.delveinsight.com/sample-request/non-small-cell-lung-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
NSCLC Emerging Drugs Profile
• Datopotamab deruxtecan: Daiichi Sankyo
• JDQ443: Novartis
• MRTX849: Mirati Therapeutics
• INBRX-106: Inhibrx
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 Pipeline Report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Intranasal
• Intrathecal
• Intravenous
• Oral
• Oral/Intravenous
• Parenteral
• Subcutaneous
• Subcutaneous/Intramuscular
• Transdermal
NSCLC Products have been categorized under various Molecule types such as
• Antisense oligonucleotide
• Gene therapy
• Hormones
• Neuropeptides
• Oligonucleotides
• Small Molecule
• Triglyceride
Learn more about the emerging NSCLC Pipeline Therapies @ NSCLC Clinical Trials Assessment- https://www.delveinsight.com/sample-request/non-small-cell-lung-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Scope of the NSCLC 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- https://www.delveinsight.com/sample-request/non-small-cell-lung-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Table of Content
1. Introduction
2. NSCLC Executive Summary
3. Non-Small-Cell Lung cancer Overview
4. NSCLC Pipeline Therapeutics
5. NSCLC Therapeutic Assessment
6. Non-Small-Cell Lung cancer DelveInsight's Analytical Perspective
7. Mid Stage Products (Phase III)
8. Datopotamab deruxtecan: Daiichi Sankyo
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II)
11. RMC-4630: REVOLUTION Medicines
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I/II)
14. GB 1211: BridgeBio Pharma
15. Drug profiles in the detailed report.....
16. Early Stage Products (Phase I)
17. BBP 398: BridgeBio Pharma.
18. Drug profiles in the detailed report.....
19. Preclinical Stage Products
20. Drug name: Company name
21. Drug profiles in the detailed report.....
22. Inactive Products
23. Non-Small-Cell Lung Cancer Companies
24. Non-Small-Cell Lung Cancer Key Products
25. Non-Small-Cell Lung Cancer Unmet Needs
26. Non-Small-Cell Lung Cancer Market Drivers and Barriers
27. Non-Small-Cell Lung Cancer Future Perspectives and Conclusion
28. Non-Small-Cell Lung Cancer Analyst Views
29. Non-Small-Cell Lung Cancer Companies
30. Appendix
For further information on the NSCLC Pipeline therapeutics, reach out to NSCLC Unmet Needs and Analyst Views- https://www.delveinsight.com/sample-request/non-small-cell-lung-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
https://www.delveinsight.com/consulting
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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