Carcinoma, Non-Small-Cell Lung
Recent clinical, regulatory, research and industry developments relating to this disease.
Time-of-day immunochemotherapy in non-small cell lung cancer: a randomized phase 3 trial.
Tumor-Infiltrating Clonal Hematopoiesis.
Recent advances in therapeutic strategies for non-small cell lung cancer.
Update 2025: Management of Non‑Small-Cell Lung Cancer.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 4 clinical trials expected to report results, the earliest in Q4 2027.
- Active recent publication activity, including 2 notable findings.
- Q4 2027SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
- Q2 2029A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
- Q3 2029A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
- Q2 2033A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
Research HighlightsViewHide
Clinical MilestonesViewHide
- 2026-05-05A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung CancerResults posted
- 2025-12-22A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing ChemotherapyResults posted
- 2025-08-29A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Subjects With Unresectable or Metastatic Melanoma or PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) in India (Keynote-593)Results posted
- 2026-07-20SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 ExpressionResults expected Q4 2027
- 2026-07-08A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)Results expected Q3 2029
- 2026-07-07A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02Results expected Q2 2029
- 2026-07-06A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)Results expected Q2 2033
- 2026-07-20ClinicalSUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 ExpressionResults expected Q4 2027
- 2026-07-08ClinicalA Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)Results expected Q3 2029
- 2026-07-07ClinicalA Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02Results expected Q2 2029
- 2026-07-06ClinicalA Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)Results expected Q2 2033
- 2026-05-05ClinicalA Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung CancerResults posted
- 2026-02-02ResearchTime-of-day immunochemotherapy in non-small cell lung cancer: a randomized phase 3 trial.Huang Z · 2026
- 2026-01-28ResearchFecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial.Duttagupta S · 2026
- 2025-12-22ClinicalA Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing ChemotherapyResults posted
- 2025-08-29ClinicalA Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Subjects With Unresectable or Metastatic Melanoma or PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) in India (Keynote-593)Results posted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is… (2025)
Approval — Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chem… (2023)
Approval — Imjudo in combination with durvalumab is indicated for the first line treatment of a… (2023)
Approval — Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment… (2019)
Approval — Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy… (2018)
Approval — Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adul… (2017)
Approval — Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents… (2015)
Approval — Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of a… (2014)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Lung Neoplasms135
- Carcinoma, Non-Small-Cell Lung133
- Immune Checkpoint Inhibitors14
- Circulating Tumor DNA11
- Immunotherapy10
- Antineoplastic Agents8
- Mutation8
- Antineoplastic Agents, Immunological6
Leading journals6
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology32
- The New England journal of medicine30
- JAMA oncology7
- Journal for immunotherapy of cancer7
- Frontiers in immunology6
- Nature communications6
Leading researchers8
- Felip E18
- Brahmer JR13
- Kim SW13
- Cho BC12
- Paz-Ares L12
- Wang J12
- Lu S11
- Planchard D10
Affiliations (unnormalised)6
- Memorial Sloan Kettering Cancer Center18
- Dana-Farber Cancer Institute12
- Samsung Medical Center12
- Asan Medical Center10
- The University of Texas MD Anderson Cancer Center10
- Hospital Universitario 12 de Octubre8
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Non-small-cell lung carcinoma is a heterogeneous group of lung cancers that includes squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is commonly considered together because these histologic types share broad treatment strategies.
NSCLC is characterized by malignant cell overgrowth with alterations in signaling, gene expression regulation, and cell proliferation. The literature grounding also emphasizes tumor microenvironment effects, immune escape, and drug resistance as important biological features, including immune checkpoint pathways such as PD-1/PD-L1 and CTLA-4.
Management includes surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. The grounding specifically supports platinum-based chemotherapy, pemetrexed, taxanes, docetaxel, camptothecin-class agents, EGFR-targeted therapy such as gefitinib and osimertinib, and immune checkpoint inhibitors such as pembrolizumab, atezolizumab, durvalumab, and nivolumab. In locally advanced disease, concurrent or sequential chemoradiotherapy is used, and guideline updates emphasize targeted therapies and immunotherapies guided by biomarkers.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.