OncRef
Skip to newsletter content
|
NSCLCJanuary 2026
0:00 / 4:27
Non-Small Cell Lung Cancer — Monthly Compass
Jan 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in Non-small cell lung cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
Built for oncologists OncRef Curated Oncology Intelligence Layer
Non-small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • Perioperative PD‑1 plus chemotherapy is converging as the default standard in resectable NSCLC, underpinned by CheckMate 77T’s event‑free survival benefit with perioperative nivolumab plus chemotherapy.
  • Important Drug Publication Updates
    • First-line osimertinib combined with platinum–pemetrexed significantly extended overall survival versus osimertinib alone in EGFR‑mutated advanced NSCLC, with increased but reversible grade ≥3 adverse events.
    • Adjuvant aumolertinib significantly improved disease-free survival in resected stage II–IIIB EGFR‑mutated NSCLC in a double-blind, randomized phase 3 trial in China.
  • Key Clinical Development Updates
    • The FDA granted Breakthrough Therapy Designation to sevabertinib for first-line unresectable or metastatic HER2‑mutant NSCLC (supported by SOHO‑01 cohort F) and to zoldonrasib for KRAS G12D‑mutated NSCLC after anti–PD‑(L)1 and platinum chemotherapy, the first BTD for a KRAS G12D inhibitor in NSCLC.
    • Regulatory momentum included FDA acceptance of Nuvalent’s NDA for zidesamtinib in ROS1‑positive NSCLC with a PDUFA date of September 18, 2026, FDA acceptance of Summit’s BLA for ivonescimab plus chemotherapy in EGFR‑mutated NSCLC post‑third‑generation EGFR TKI with a PDUFA date of November 14, 2026, and Orphan Drug Designation for gotistobart in squamous NSCLC alongside Nuvalent’s planned 2026 submissions for ALK and ROS1 expansions.
  • Important Clinical Trial Publications
    • The SACHI phase 3 trial showed savolitinib plus osimertinib significantly extended progression‑free survival compared with chemotherapy in EGFR mutation‑positive, MET‑amplified NSCLC after EGFR TKI therapy in China, with favorable tolerability.
    • A phase 3 study demonstrated that sacituzumab tirumotecan improved progression‑free and overall survival versus platinum‑based chemotherapy in EGFR‑mutated advanced NSCLC after EGFR‑TKI therapy while maintaining a manageable safety profile.
  • Key Conference Updates
    • January programs at TASLC and the IV International Thoracic Cancer Debates emphasized accelerating placement questions for anti‑Trop2 ADCs and HER2‑altered disease and featured focus on PD‑1×VEGF bispecifics with chemo‑sparing potential, alongside sessions on MRD, multi‑omics, and AI for optimizing immunotherapy selection and sequencing.
  • Emerging Themes & Macro-Trends
    • Stakeholders are pivoting toward MRD infrastructure and AI‑enabled prognostics, life‑cycle planning for ADCs and PD‑1×VEGF bispecifics as backbones, and building rare‑fusion networks to capture biomarker‑defined segments.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-01-01 and 2026-01-31 about Non-small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Bayer reported that the FDA granted Breakthrough Therapy Designation to sevabertinib (Hyrnuo) for first-line treatment of patients with unresectable or metastatic HER2‑mutant NSCLC. The company noted this first‑line BTD follows sevabertinib’s prior U.S. accelerated approval in the previously treated setting and is supported by cohort F of the SOHO‑01 study.¹ (read more)
  • Revolution Medicines announced FDA Breakthrough Therapy Designation for zoldonrasib (RMC‑9805) to treat adults with KRAS G12D‑mutated locally advanced or metastatic NSCLC after anti–PD‑1/PD‑L1 therapy and platinum chemotherapy. The BTD is based on data from the phase 1 RMC‑9805‑001 monotherapy cohort and represents the first BTD for an investigational drug targeting KRAS G12D in NSCLC.² (read more)
  • Nuvalent provided a January operating update confirming FDA acceptance of the NDA for zidesamtinib in ROS1‑positive NSCLC after at least one prior ROS1 TKI, with a PDUFA target action date of September 18, 2026. The company also outlined 2026 plans, including a planned NDA submission for neladalkib (NVL‑655) in pre‑treated ALK‑positive NSCLC and a planned data submission to FDA for potential zidesamtinib indication expansion in TKI‑naïve ROS1‑positive NSCLC.³ (read more)
  • Summit Therapeutics announced submission of a BLA to the FDA seeking approval of ivonescimab (PD‑1/VEGF bispecific) plus chemotherapy for EGFR‑mutated locally advanced or metastatic non‑squamous NSCLC after third‑generation EGFR TKI therapy. The filing is supported by the global phase 3 HARMONi trial; Summit indicated it anticipated a potential decision in 4Q 2026 pending acceptance.⁴ (read more)
  • BioNTech and OncoC4 reported FDA Orphan Drug Designation for gotistobart (BNT316/ONC‑392), a CTLA‑4–targeting Treg‑depleting antibody, for squamous NSCLC. The partners highlighted the ongoing pivotal phase 3 PRESERVE‑003 trial in metastatic squamous NSCLC post anti‑PD‑(L)1 and platinum chemotherapy.⁵ (read more)
  • Summit Therapeutics later disclosed FDA acceptance for filing of the ivonescimab BLA in EGFR‑mutated NSCLC post‑TKI, with a PDUFA goal action date of November 14, 2026. The accepted application covers ivonescimab plus platinum‑doublet chemotherapy versus placebo plus chemotherapy as evaluated in HARMONi.⁶ (read more)
Publications Related to Approved Drugs
Phase 3
osimertinib
Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. First-line treatment with osimertinib combined with platinum-pemetrexed chemotherapy significantly extended overall survival compared to osimertinib monotherapy in patients with EGFR-mutated advanced non-small cell lung cancer, despite an increased risk of reversible grade 3 or higher adverse events.
Phase 3
dacomitinib
Real-world use of and clinical outcomes with dacomitinib as first-line therapy in Asian patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer: Final analysis of the ARIA study. The ARIA study, the largest real-world study of dacomitinib, demonstrated substantial clinical efficacy and a safety profile consistent with previous findings, supporting its use as a first-line treatment for Asian patients with EGFR mutation-positive advanced NSCLC.
Phase 2
tarlatamab-dlle
FDA Approval Summary: Tarlatamab for the Treatment of Extensive Stage Small Cell Lung Cancer. The FDA granted accelerated approval to tarlatamab-dlle for adult patients with extensive stage small cell lung cancer who have progressed on or after platinum-based chemotherapy, based on an overall response rate of 40% and a median duration of response of 9.7 months in the DeLLphi-301 trial.
Phase 3
atezolizumab, atezolizumab and hyaluronidase-tqjs
Reciprocal regulation of hMENA and TGF-β signaling in cancer-associated fibroblasts promotes EMT, immunosuppression, poor prognosis, and ICT resistance in NSCLC. Overexpression of hMENA in cancer-associated fibroblasts (CAFs) defines a myofibroblast-like subset driven by TGF-β signaling, which sustains TGF-β1-mediated crosstalk between cancer cells and CAFs, impairs T-cell functionality, and correlates with poor patient prognosis and resistance to immune checkpoint therapies in NSCLC.
New Publications Related to Drugs in Clinical Trial Development
Phase 2
Perioperative penpulimab-based combination therapy in patients with resectable non-small cell lung cancer (ALTER-L043): an open-label, multicenter, randomized, phase II trial. This phase II trial (ALTER-L043) showed that perioperative penpulimab plus anlotinib, with or without neoadjuvant chemotherapy, yielded promising efficacy and a manageable safety profile in resectable NSCLC, indicating its potential as a viable treatment option.
Phase 2
Osimertinib with or without savolitinib as first-line treatment for MET-aberrant, EGFR-mutant NSCLC: randomized phase 2 trial (FLOWERS). The FLOWERS phase 2 trial demonstrated that osimertinib combined with savolitinib significantly improved the objective response rate to 90.5% in treatment-naïve, MET-aberrant, EGFR-mutant NSCLC patients, compared to 60.9% with osimertinib alone, with a manageable safety profile.
Phase 3
TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non-small cell lung cancer. This phase 3 study (TROPION-Lung12) is evaluating the combination of datopotamab deruxtecan and rilvegostomig as adjuvant therapy for stage I NSCLC patients with ctDNA-positive status or high-risk pathologic features, with the primary goal of improving disease-free survival.
Phase 2
Minimal Residual Disease Enhances Prognostic Stratification Beyond Pathological Response in Resectable Non-Small Cell Lung Cancer. An analysis from the NADIM II trial revealed that minimal residual disease (MRD) detection post-surgery or during adjuvant therapy significantly correlates with poorer event-free and overall survival in resectable NSCLC, providing enhanced prognostic value beyond pathological response.
Phase 1
MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naïve metastatic non-small-cell lung cancer. The MAGELLAN phase 1B study investigated durvalumab plus chemotherapy, with or without oleclumab, in treatment-naïve metastatic NSCLC, finding a manageable safety profile but no significant efficacy improvements, thus limiting further development of this combination.
Phase 2
Long-term outcomes of preoperative nivolumab with or without relatlimab in patients with resectable non-small-cell lung cancer (NEOpredict-Lung). The NEOpredict-Lung trial showed encouraging long-term efficacy and survival rates with short-course preoperative nivolumab, with or without relatlimab, in resectable NSCLC, suggesting favorable outcomes compared to existing chemo-immunotherapy regimens.
Phase 2
Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: Pooled analysis of phase 1 and phase 2 trials. A pooled analysis of phase 1 and 2 trials demonstrated that izalontamab brengitecan, an EGFR-HER3 bispecific antibody-drug conjugate, exhibited promising antitumor activity and a manageable safety profile in heavily pretreated EGFR-mutated NSCLC patients who had progressed on prior EGFR TKI therapy.
Phase 2
Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. The FMT-LUMINate phase 2 trial showed that fecal microbiota transplantation combined with immune checkpoint inhibitors resulted in high objective response rates (80% in NSCLC) and a safe profile, suggesting that the elimination of deleterious gut bacteria is essential for therapeutic benefit.
Phase 3
Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial. The SACHI phase 3 trial reported that savolitinib combined with osimertinib significantly extended progression-free survival compared to chemotherapy in Chinese patients with EGFR mutation-positive, MET-amplified NSCLC who had progressed on EGFR TKI therapy, while maintaining a favorable tolerability profile.
Phase 3
Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis. An exploratory analysis of the CheckMate 77T phase 3 study demonstrated that perioperative nivolumab combined with neoadjuvant chemotherapy significantly improved event-free survival and pathological complete response rates in patients with stage III N2 resectable NSCLC, suggesting that N2 status may not be a poor prognostic indicator with this immunotherapy.
Phase 3
Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. A phase 3 trial demonstrated that sacituzumab tirumotecan significantly improved progression-free survival and overall survival compared to platinum-based chemotherapy in patients with EGFR-mutated advanced NSCLC who had progressed after EGFR-TKI therapy, while maintaining a manageable safety profile.
Phase 2
Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (KUNPENG): a single-arm, multi-cohort, multicentre, phase 2 study. The KUNPENG phase 2 study demonstrated that vebreltinib, a potent and selective MET inhibitor, showed promising antitumor activity with an objective response rate of 48.8% in patients with MET amplification-driven advanced NSCLC, including those previously treated or chemotherapy-naive.
Phase 1
Radiotherapy induces YTHDF2 in dendritic cells impairing cross-presentation and T cell function. Research linked to a clinical trial identified YTHDF2 as a radiation-induced immune checkpoint in dendritic cells, which impairs MHC-I cross-presentation and CD8+ T cell activation, suggesting that targeting YTHDF2 could be a strategy to overcome radiotherapy resistance and metastasis.
Phase 1
Survivin recombinant overlapping peptide (ROP) vaccine in advanced solid tumours: a first-in-human, multicentre, open-label, phase 1a dose-escalation study. The OVM-200-100 phase 1a trial of a survivin recombinant overlapping peptide vaccine in advanced solid tumors, including NSCLC, showed good tolerability and induced robust humoral and cellular immune responses, with preliminary evidence of disease stabilization, especially at the 2000 μg dose.
Phase 3
Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. The ARTS phase 3 trial showed that adjuvant aumolertinib significantly improved disease-free survival in Chinese patients with resected stage II-IIIB EGFR-mutated NSCLC, exhibiting substantial clinical benefits and a manageable safety profile suitable for the adjuvant setting.
Phase 3
Adjuvant Chemotherapy with Traditional Chinese Herbal Granules Versus Placebo in Resected Non-Small Cell Lung Cancer: Updated Survival Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. An updated analysis of the NALLC trial indicated a potential trend towards improved disease-free survival in early-stage NSCLC patients receiving adjuvant chemotherapy combined with traditional Chinese medicine, with notable benefits observed in stage Ib patients.
Phase 1
Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. The first-in-human phase 1 study of the novel ALK inhibitor dirozalkib showed favorable safety, pharmacokinetics, and promising antitumor activity in patients with advanced ALK-rearranged NSCLC, especially in ALK inhibitor-naive individuals.
Phase 3
Four-Year Outcomes for Nivolumab With Chemotherapy and Bevacizumab in Patients With Nonsquamous NSCLC in the TASUKI-52. The final analysis of the TASUKI-52 phase 3 trial demonstrated that nivolumab combined with carboplatin, paclitaxel, and bevacizumab provided significant long-term overall survival and progression-free survival benefits in patients with advanced nonsquamous NSCLC, reinforcing its role as a first-line treatment option.
Phase 2
Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials. A pooled analysis of two phase II trials (, ) revealed that durvalumab-containing combination therapy demonstrated promising efficacy in recurrent or metastatic pulmonary sarcomatoid carcinoma, independent of PD-L1 expression, and suggested a lower CD4+/CD8+ ratio as a potential biomarker for favorable disease control.
Phase 1
Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. The DRAGON phase 1 trial investigated linavonkibart combined with pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors, showing a manageable safety profile and confirmed objective response rates in various cancers, including clear cell renal cell cancer and melanoma.
Conference
Major Conference Updates
Conference Information
  • 2026 TASLC International Symposium on Treatment Advances in Lung Cancer; Taipei, Taiwan (National Taiwan University Hospital Cancer Center Branch); January 10–11, 2026. (read more)
  • IV International Thoracic Cancer Debates 2026; Las Palmas de Gran Canaria, Spain (Auditorio Alfredo Kraus); January 30–31, 2026. (read more)
  • Best of NACLC 2025 (IASLC webinar); Virtual (Zoom); January 5, 2026. (read more)
  • J.P. Morgan Healthcare Conference; San Francisco, CA; January 2026 (company presentation/press release). (read more)
  • Overall sentiment: January meetings converged on perioperative immunotherapy becoming foundational in early-stage NSCLC, while ADCs and bispecifics—especially PD‑1×VEGF constructs—drove momentum; precision tools (MRD, multi‑omics, AI) are poised to sharpen selection and sequencing. (read more)
  • Theme 1: Perioperative IO and Early Interception Ascendancy
    • Significance: Broad agreement that neoadjuvant/adjuvant PD‑1–based regimens are shifting curative‑intent standards; debate now centers on surgical integration and biomarker-guided selection. (read more)
    • Mechanism insights / clinical impact: CheckMate 77T established event‑free survival benefit for perioperative nivolumab + chemotherapy; programs highlighted “Immunotherapy in NSCLC. Localize disease” and the evolving role of surgery/biomarkers. (read more)
    • Patient populations affected: Resectable stage II–III (including N2) worldwide; perioperative IO emphasized across Europe/North America/Asia. (read more)
  • Theme 2: ADCs Push Into Diverse Molecular Niches
    • Significance: Dedicated sessions (“ADCs double molecules”) signal accelerating adoption and placement questions for anti Trop2 ADCs and HER2‑altered disease. (read more)
    • Mechanism insights / clinical impact: Programs juxtaposed “HER2 deregulated NSCLC. ADC or TKIs treatment?” underscoring sequencing trade‑offs and toxicity management; perioperative and metastatic settings both in scope. (read more)
    • Patient populations affected: Pretreated HER2‑altered and EGFR exon20ins NSCLC; global applicability highlighted at ITCD. (read more)
  • Theme 3: Bispecifics (PD‑1×VEGF and Beyond) Consolidate Momentum
    • Significance: Conference focus on “Bispecific Antibodies That Starve and Activate: PD‑1 and VEGF Dual Blockade” aligned with corporate updates on ivonescimab, signaling competitive, chemo‑free combinations. (read more)
    • Mechanism insights / clinical impact: Single‑molecule co‑targeting (immune activation + anti‑angiogenesis) may streamline efficacy and tolerability versus separate agents and concentrate activity in the TME. (read more)
    • Patient populations affected: Advanced/metastatic NSCLC across PD‑L1 strata; multinational trial footprints expected. (read more)
  • Theme 4: Precision Diagnostics and AI to Optimize IO Benefit
    • Significance: MRD implementation (“Challenges of using and adapting MRD in lung cancer”) and multi‑omics featured prominently; AI models for IO outcomes gained visibility. (read more)
    • Mechanism insights / clinical impact: Atezolizumab‑treated NSCLC datasets enabled a mechanistic learning model (TALN‑kML) integrating tumor kinetics with albumin/LDH/neutrophils to improve OS prediction—informing therapy continuation/combination strategies. (read more)
    • Patient populations affected: IO‑treated advanced NSCLC; early‑stage patients considered for MRD‑guided escalation/de‑escalation. (read more)
  • Significance
    • Expected clinical or translational readouts: Near‑term data flow at TTLC 2026 (Huntington Beach, February 18–21) will refine perioperative IO, ADC positioning, and bispecific strategies. (read more)
    • Regulatory or policy implications: Perioperative nivolumab’s established benefit focuses stakeholders on biomarker infrastructure (MRD, multi‑omics) and real‑world implementation pathways. (read more)
    • Potential shifts in standard of care: Perioperative PD‑1 + chemo as default in resectable disease; expanding roles for anti Trop2 ADCs and PD‑1×VEGF bispecifics as chemo‑sparing backbones. (read more)
    • Strategic implications: Prioritize MRD capabilities, invest in ADC/bispecific life‑cycle planning, and build rare‑fusion networks (e.g., zenocutuzumab/eNRGy signals) to capture biomarker‑defined segments. (read more)
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in Non-small cell lung cancer updated from 2026-01-01 to 2026-01-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation--1---1
Not Yet Recruiting671724137
Recruiting4933454411173
Available-------
Approved for Marketing-------
Active, Not Recruiting242031419-98
Completed1-4-3-8
Total80609810672317
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: MK-4700, : Pembrolizumab NCT06894771 COMPLETED A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors 2025-11-24
: Nivolumab NCT03025256 ACTIVE_NOT_RECRUITING Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD) 2025-12-30
Leucovorin, Zimberelimab, Fluorouracil, AB598, Oxaliplatin NCT05891171 ACTIVE_NOT_RECRUITING A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies 2026-03
sasanlimab, PF-08046037 NCT06974734 ACTIVE_NOT_RECRUITING AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES 2026-04-30
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Atezolizumab, Tiragolumab NCT03563716 COMPLETED A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer 2025-11-24
AZD9291 NCT02442349 COMPLETED A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients With Locally Advanced/Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene. 2025-11-28
Erlotinib, : LY2875358 NCT01897480 COMPLETED A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib 2026-01-08
Durvalumab, Sotorasib NCT06333678 COMPLETED A Randomized Phase II Study of Sotorasib Versus Continued Consolidation Durvalumab in Patients With KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer (LANSCLC) With Persistent ctDNA Defined Minimal Residual Disease 2026-01-27
Patritumab Deruxtecan (Up-Titration), Patritumab Deruxtecan (Fixed dose) NCT04619004 ACTIVE_NOT_RECRUITING HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) 2026-01-30
Trilaciclib NCT06370416 ENROLLING_BY_INVITATION A Single Arm, Exploratory Clinical Study on the Prevention of Bone Marrow Suppression Caused by Platinum Containing Chemotherapy in Advanced Non-small Cell Lung Cancer With Trilaciclib 2026-01-31
Adagrasib NCT05673187 ACTIVE_NOT_RECRUITING A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status 2026-03
Atezolizumab, Cisplatin, Pemetrexed, Docetaxel NCT04367311 ACTIVE_NOT_RECRUITING A Phase II Study of Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396 2026-03
Alirocumab and Cemiplimab NCT05553834 ACTIVE_NOT_RECRUITING A Phase II Study of PCSK9 Inhibitor Alirocumab and PD-1 Inhibitor Cemiplimab in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung Cancer: TOP2201 2026-03-01
Ramucirumab, Carboplatin, Paclitaxel NCT04332367 RECRUITING Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab 2026-04
Lorlatinib NCT05740943 ACTIVE_NOT_RECRUITING Induction Lorlatinib for ALK Fusion Locally Advanced Non-small Cell Lung Cancer: A Prospective, Single Arm, Open-label Phase 2 Study 2026-04-30
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
AZD9291 80 mg/40 mg + placebo, Placebo AZD9291 80 mg/ 40 mg, Erlotinib 150/100 mg, Placebo Erlotinib 150/100mg, Gefitinib 250 mg, Placebo Gefitinib 250 mg NCT02296125 COMPLETED A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer. 2025-11-20
Atezolizumab, Tiragolumab NCT04294810 COMPLETED A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer 2025-12-30
Carboplatin, Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Gemcitabine, Cisplatin, Pemetrexed, Nab-paclitaxel NCT03456063 COMPLETED A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer 2025-12-31
: Pembrolizumab, Niraparib NCT04475939 ACTIVE_NOT_RECRUITING A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L) 2026-03-06
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
NOTICE: This communication may contain confidential or proprietary information of Oncology Reference, Inc. Data is compiled from publicly available and third-party sources and integrated with proprietary Oncology Reference database mappings, developed and maintained by PhD scientists and advanced AI systems, for organization and analysis. While reasonable efforts are made to ensure accuracy and timeliness, Oncology Reference, Inc. makes no representation or warranty, express or implied, regarding accuracy, completeness, or fitness for a particular purpose. Information may contain errors, omissions, or be subject to change without notice. This material is for informational purposes only and is not medical advice, regulatory guidance, investment advice, or a substitute for professional judgment. Users must independently verify all information.

Oncology Reference, Inc. and its affiliates disclaim all liability for any loss or damage arising from use of or reliance on this information. By using this information, you agree that disputes will be governed by Delaware law and resolved by binding arbitration in Delaware.
California residents waive California Civil Code § 1542. All trademarks are the property of their respective owners.
© 2025 Oncology Reference, Inc. All rights reserved.

CONFIDENTIALITY NOTICE: If you are not the intended recipient, please notify the sender, delete this message, and refrain from using or disclosing its contents.