Non-Small-Cell Lung Cancer (NSCLC) - Pipeline Insight, 2025

This “Non-Small-Cell Lung cancer (NSCLC) - Pipeline Insight, 2025” report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in Non-Small-Cell Lung cancer (NSCLC) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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

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

Non-small cell lung cancer is the most common type of lung cancer. With this disease, cancer cells originate in your lung tissues. Non-small cell lung cancer grows slowly compared to small cell lung cancer but it often spreads to other parts of your body by the time it’s diagnosed. So, early detection and treatment are essential. Small cell lung cancer gets its name because the cancer cells look small and round under a microscope. With non-small cell lung cancer, the cancer cells are larger. Typically, small cell lung cancer grows faster than non-small cell lung cancer. Even so, non-small cell lung cancer is often diagnosed after the cancer has spread to other areas of your body. That’s why early detection and treatment are so important. Lung cancer is a diagnosis that approximately 230,000 United States citizens will receive annually. Deaths are estimated at 135,000 patients per year. Lung cancer deaths have become more numerous than the deaths from prostate, breast, brain, and colorectal cancer combined. It has now become the most common cause of cancer deaths in men and the second most common in women. However, this statistic is now declining, largely due to anti-smoking campaigns and decreased tobacco use in the United States. The foundation of lung tumor classification follows the 2015 World Health Organization (WHO) classification of lung tumors. This classification system relies on immunohistochemistry and light microscopy in order to better guide treatment and determine a prognostic course. Non-small cell lung cancer (NSCLC) is a term that includes a variety of different lung cancers, most notably adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Adenocarcinoma is the most common type of lung cancer in this category and includes one-half of all lung cancer cases. Squamous cell carcinoma is another type of NSCLC that had been the most frequently diagnosed lung cancer before this time. Squamous cell carcinoma (SCC) usually originates at the origin of the tracheobronchial tree, but more cases are now diagnosed in the periphery of the lung. Large cell carcinoma is a subset of NSCLC that is a diagnosis of exclusion. It is poorly differentiated and cannot be further classified by immunohistochemistry (IHC) or electron microscopy. The etiology of NSCLC can be further categorized into avoidable and unavoidable risk factors. The most well-known avoidable risk factor for NSCLC is inhaled tobacco use. Other causes of lung cancer include alcohol use, environmental exposure to secondhand smoke, asbestos, radon, arsenic, chromium, nickel, as well as exposure to ionizing radiation, and polycyclic aromatic hydrocarbons.

Diagnosis should include a complete blood count (CBC) as well as a complete metabolic panel (CMP) as this will further evaluate for any potential hematologic or electrolyte sequelae from NSCLC. This could include hypercalcemia or elevated alkaline phosphatase in the setting of bony metastasis. Imaging should begin with a chest radiograph as the presentation of NSCLC can be nonspecific. If lung cancer is suspected, further evaluation with computed tomography (CT) imaging would likely be warranted to further characterize the pathology noted on the chest radiograph. Tissue biopsy will be needed for histopathologic and immunohistochemistry evaluation to form the diagnosis of NSCLC.

Different types of treatments are available for patients with non-small cell lung cancer. Some treatments are standard (the currently used treatment), and some are being tested in clinical trials. When clinical trials show that a new treatment is better than the standard treatment, the new treatment may become the standard treatment. Patients may want to think about taking part in a clinical trial. Some clinical trials are open only to patients who have not started treatment. The following types of treatment are used: Surgery, Radiation therapy, Chemotherapy, Targeted therapy, Immunotherapy, Laser therapy, Photodynamic therapy (PDT), Cryosurgery. An effective treatment for non-small cell cancer depends on the cancer’s stage. Surgery to remove all or only part of the lung is usually required if the cancer hasn’t spread. Treatment varies based on the patient's functional status, comorbidities, tumor stage, and molecular characteristics of the disease. The management of NSCLC depends on an interprofessional approach for the care of the patient. This begins with prevention, in which the primary clinician has an integral role in smoking cessation counseling. The primary clinician also has an integral role in the potential early diagnosis of this disease with lung cancer screening before it evolves to advanced stages where prognosis worsens.

'Non-Small-Cell Lung cancer (NSCLC) - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Non-Small-Cell Lung cancer (NSCLC) pipeline landscape is provided which includes the disease overview and Non-Small-Cell Lung cancer (NSCLC) treatment guidelines. The assessment part of the report embraces, in depth Non-Small-Cell Lung cancer (NSCLC) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non-Small-Cell Lung cancer (NSCLC) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Non-Small-Cell Lung cancer (NSCLC) R&D. The therapies under development are focused on novel approaches to treat/improve Non-Small-Cell Lung cancer (NSCLC) .

Non-Small-Cell Lung cancer (NSCLC) Emerging Drugs Chapters

This segment of the Non-Small-Cell Lung cancer (NSCLC) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Non-Small-Cell Lung cancer (NSCLC) Emerging Drugs

V940: Merck Sharp & Dohme LLC

V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumor. It is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. The drug is in Phase III stage for the treatment of NSCLC.

QL1706: Qilu Pharmaceutical Co., Ltd.

QL1706 is an investigational bifunctional antibody with additional anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibody could increase the anti-tumor effect of anti-programmed cell death 1 (PD-1) antibody. QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD-1 IgG4 and anti-CTLA4 IgG1 antibodies produced by a single cell line. The drug is in Phase III stage for the treatment of NSCLC.

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

Zenocutuzumab (MCLA-128; Zeno) is a Biclonics antibody that overcomes HER3 mediated NRG1 (or NRG1 fusion) signaling in tumor cells. Zeno docks on HER2, then binds to and blocks the NRG1 fusion-HER3 interaction and HER3 heterodimerization with HER2. It has a dual mechanism against cancer, as it prevents NRG1 fusions from binding to the protein HER3 and it blocks the interaction of HER3 with HER2, which the cancer cells depend on to survive and multiply. Currently, the drug is in Phase II stage for the treatment of NSCLC.

ZW49: Zymeworks BC Inc.

ZW49 (zanidatamab zovodotin) is a bispecific anti-HER2 ADC that is based on the same antibody framework as ZW25 but armed with a cytotoxic payload. A biparatopic (targeting two different non-overlapping epitopes on ERBB2, on extracellular domains 2 (ECD2) and 4 (ECD4). ZW25 is an anti-HER2 biparatopic antibody which binds to the same domains as trastuzumab and pertuzumab. ZW25 simultaneously binds two distinct sites on HER2, a protein expressed on many types of cancer cells. This unique design results in multiple mechanisms of action, including dual HER2 signal blockade, increased antibody binding, receptor clustering, and removal of HER2 from the cell surface, and potent effector function. ZW49 is in Phase I of clinical trials for the treatment of non-small cell lung cancer.

Non-Small-Cell Lung cancer (NSCLC) : Therapeutic Assessment

This segment of the report provides insights about the different Non-Small-Cell Lung cancer (NSCLC) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Non-Small-Cell Lung cancer (NSCLC)

• There are approx. 100+ key companies which are developing the therapies for Non-Small-Cell Lung cancer (NSCLC). The companies which have their Non-Small-Cell Lung cancer (NSCLC) drug candidates in the most advanced stage, i.e. Phase III include, Merck Sharp & Dohme LLC.

Phases

The report covers around 120+ 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

Route of Administration

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Non-Small-Cell Lung cancer (NSCLC): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Non-Small-Cell Lung cancer (NSCLC) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non-Small-Cell Lung cancer (NSCLC) drugs.

Non-Small-Cell Lung cancer (NSCLC) Report Insights

• Non-Small-Cell Lung cancer (NSCLC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Non-Small-Cell Lung cancer (NSCLC) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Non-Small-Cell Lung cancer (NSCLC) drugs?
• How many Non-Small-Cell Lung cancer (NSCLC) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Non-Small-Cell Lung cancer (NSCLC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Non-Small-Cell Lung cancer (NSCLC) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Non-Small-Cell Lung cancer (NSCLC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Merck Sharp & Dohme LLC
• Suzhou Puhe Pharmaceutical Technology Co., LTD
• Merus N.V.

Zymeworks BC Inc.

Cytos Biotechnology

• Exelixis
• ProfoundBio US Co.

Beijing Pearl Biotechnology Limited Liability Company

• Pfizer
• OncoResponse, Inc.

Next Point Therapeutics, Inc.

Light Chain Bioscience - Novimmune SA

• Medolution Ltd.

Immunitas Therapeutics

• Shanghai Henlius Biotech

Key Products

• V940
• YK-029A
• Zenocutuzumab (MCLA-128)
• ZW49
• CMP 001
• XL092
• PRO1184
• PLB1001
• PF-07257876
• OR2805
• NPX267
• NI-1801
• Keynatinib
• IMT-009
• HLX301

This product will be delivered within 3-5 business days.