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NSCLCMay 2026
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Non-Small Cell Lung Cancer — Monthly Compass
May 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.
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non-small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • Sunvozertinib significantly prolonged progression‑free survival and improved objective response versus platinum chemotherapy as first‑line therapy for advanced NSCLC with EGFR exon 20 insertion mutations.
    • Adjuvant selpercatinib significantly prolonged event‑free survival compared with placebo in early‑stage RET fusion‑positive NSCLC following definitive therapy, supporting integration of targeted therapy into curative‑intent care.
  • Important Drug Publication Updates
    • The 7‑year CROWN update showed first‑line lorlatinib in advanced ALK‑positive NSCLC achieved unprecedented durability with median progression‑free survival not reached and a 55% 7‑year PFS rate, alongside absence of new intracranial progression events after 30 months.
  • Key Clinical Development Updates
    • FDA accepted Nuvalent’s NDA for neladalkib with Priority Review for TKI‑pretreated ALK‑positive NSCLC (PDUFA November 27, 2026) and continued review of zidesamtinib for ROS1‑positive NSCLC (PDUFA September 18, 2026) with a planned TKI‑naïve label expansion filing in 2H 2026.
    • FDA granted Priority Review to a first‑line sNDA for HYRNUO (sevabertinib) in HER2‑mutated NSCLC, accepted an sNDA to update IBTROZI (taletrectinib) efficacy with a January 4, 2027 action date, provided positive Type C feedback enabling LP‑300 HARMONIC Phase 2 refinements in never‑smokers, and cleared an IND for oral elraglusib for a Phase 1/2 trial including NSCLC.
  • Important Clinical Trial Publications
    • First‑line sacituzumab tirumotecan plus pembrolizumab significantly prolonged progression‑free survival versus pembrolizumab alone in PD‑L1‑positive advanced NSCLC without targetable alterations.
    • The STARLET joint analysis found adding upfront stereotactic radiosurgery to osimertinib did not improve 12‑month intracranial progression‑free survival in EGFR‑mutated NSCLC with asymptomatic brain metastases.
  • Key Conference Updates
    • At ASCO 2026, PD‑(L)1×VEGF bispecifics advanced with a significant overall survival benefit for ivonescimab plus chemotherapy versus PD‑1 plus chemotherapy in first‑line squamous NSCLC (HARMONi‑6, HR=0.66) and encouraging first‑line activity for pumitamig plus chemotherapy, while amivantamab plus lazertinib showed prolonged benefit in atypical EGFR‑mutant disease and KRAS strategies progressed with divarasib plus pembrolizumab and darlifarnib plus adagrasib showing responses including KRAS inhibitor–experienced tumors.
  • Emerging Themes & Macro-Trends
    • NSCLC development is coalescing around immunomodulatory bispecifics challenging PD‑1 plus chemotherapy, accelerated movement of precision targets into first‑line and adjuvant settings, and KRAS‑pathway intensification via rational combinations.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-05-01 and 2026-05-31 about non-small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Nuvalent announced that the FDA accepted the NDA for neladalkib, granting Priority Review for TKI-pretreated advanced ALK-positive NSCLC and assigning a PDUFA target action date of November 27, 2026; the update also noted that zidesamtinib’s NDA for ROS1-positive NSCLC remains under FDA review. The company highlighted commercial readiness activities for multiple potential 2026 launches. (prnewswire.com) ¹ (read more)
  • Nuvalent’s first-quarter 2026 update reported NDA submission for neladalkib in TKI-pretreated ALK-positive NSCLC and reiterated that the NDA for zidesamtinib in ROS1-positive NSCLC is under FDA review with a PDUFA date of September 18, 2026. The company also outlined plans to seek a label expansion for zidesamtinib in TKI-naïve ROS1-positive NSCLC in the second half of 2026. (prnewswire.com) ² (read more)
  • Bayer reported the FDA granted Priority Review to a supplemental NDA for HYRNUO (sevabertinib) as first-line therapy for adults with HER2-mutated locally advanced or metastatic NSCLC; HYRNUO is not currently approved in the first-line setting. The company referenced the drug’s November 2025 U.S. accelerated approval in previously treated disease and ongoing confirmatory efforts. (bayer.com) ³ (read more)
  • Nuvation Bio announced FDA acceptance of an sNDA for IBTROZI (taletrectinib) to update efficacy (including duration of response) in advanced ROS1-positive NSCLC, with a target FDA action date of January 4, 2027. The filing fulfills a post‑marketing commitment and incorporates additional follow-up from pivotal TRUST studies. (investors.nuvationbio.com) ⁴ (read more)
  • Lantern Pharma reported a successful outcome to its FDA Type C meeting request for the Phase 2 HARMONIC trial of LP‑300 in never‑smokers with NSCLC, indicating FDA raised no objections to key proposed protocol amendments. The company stated the feedback would support refinements to enrollment focus and trial design. (s206.q4cdn.com) ⁵ (read more)
  • Actuate Therapeutics disclosed FDA clearance of an IND for oral elraglusib, enabling a Phase 1/2 study in advanced solid tumors including NSCLC, with trial initiation planned for the second half of 2026 pending site activation. The program aims to compare oral exposure and activity relative to the prior IV formulation. (nasdaq.com) ⁶ (read more)
Conference
Major Conference Updates
Conference Information
  • ASCO 2026 Annual Meeting, Chicago, Illinois, May 29–June 2, 2026. (read more)
  • Overall takeaways: NSCLC momentum favors immunomodulatory bispecifics challenging PD-1 + chemotherapy, accelerated expansion of precision targets into 1L and adjuvant settings, and KRAS-pathway intensification via rational combinations. (read more)
  • Theme 1: PD-(L)1 × VEGF Bispecifics Reshape 1L Standards
    • Significance: Practice-informing OS signal in squamous 1L and multi-program validation position this class to compete head-to-head with PD‑1 + chemotherapy across PD‑L1 strata. (read more)
    • Mechanism insights / clinical impact: Ivonescimab + chemotherapy improved overall survival vs tislelizumab + chemotherapy in HARMONi‑6 (reported HR=0.66), consistent with dual immune‑angiogenic modulation; BioNTech’s pumitamig (PD‑L1 × VEGF‑A) + chemotherapy in ROSETTA Lung‑02 showed encouraging 1L activity, informing an ongoing Phase 3. (read more)
    • Patient populations affected: Previously untreated advanced squamous NSCLC (HARMONi‑6) and broad, driver‑negative 1L NSCLC (ROSETTA Lung‑02). (read more)
  • Theme 2: Targeted Therapy Pushes Earlier—RET Adjuvant and EGFR exon20ins Frontline
    • Significance: Precision agents are moving into curative‑intent and 1L spaces, signaling a tightening link between molecular testing and therapeutic selection. (read more)
    • Mechanism insights / clinical impact: Adjuvant selpercatinib reduced recurrence/progression risk in early‑stage RET‑positive NSCLC; sunvozertinib outperformed platinum chemotherapy as first‑line therapy in EGFR exon20ins disease (Abstract LBA8500). (read more)
    • Patient populations affected: Resected stage IB–IIIA RET‑altered NSCLC and treatment‑naive metastatic EGFR exon20ins NSCLC globally. (read more)
  • Theme 3: EGFR Space Diversifies—Amivantamab‑Based Regimens for Atypical Mutations
    • Significance: Beyond classical EGFR mutations, bispecific EGFR‑MET targeting plus CNS‑active TKIs aims to broaden benefit and durability. (read more)
    • Mechanism insights / clinical impact: CHRYSALIS‑2 (amivantamab‑vmjw + lazertinib) reported prolonged clinical benefit first‑line in atypical EGFR‑mutated NSCLC, supporting regimen flexibility and potential to address resistance heterogeneity. (read more)
    • Patient populations affected: Advanced NSCLC with atypical EGFR mutations initiating first‑line targeted therapy. (read more)
  • Theme 4: KRAS Pathway Intensification—Chemo‑Free IO and Resistance‑Bypass Combos
    • Significance: Early 1L IO + KRAS G12C strategies and post‑KRASi salvage combinations target durability limits of monotherapy. (read more)
    • Mechanism insights / clinical impact: Divarasib + pembrolizumab (Krascendo‑170) advances 1L KRAS G12C+ NSCLC; darlifarnib (FTI) + adagrasib achieved confirmed responses (including KRASi‑experienced NSCLC) via mTORC1‑RHEB pathway blockade. (read more)
    • Patient populations affected: 1L KRAS G12C–mutated NSCLC and heavily pretreated KRAS G12C tumors, including prior KRAS inhibitor exposure. (read more)
  • Significance
    • Expected clinical or translational readouts: ROSETTA Lung‑02 Phase 3 data, Krascendo‑2 progression, and full HARMONi‑6 OS updates will define competitive positioning vs PD‑1 standards. (read more)
    • Regulatory or policy implications: HARMONi‑6 OS and 1L exon20ins data could catalyze submission pathways and guideline discussions for sq‑NSCLC and EGFR exon20ins, respectively. (read more)
    • Potential shifts in standard of care: Movement toward ivonescimab + chemotherapy in 1L squamous, sunvozertinib in 1L exon20ins, and targeted adjuvant therapy (selpercatinib) in RET‑positive early NSCLC. (read more)
    • Strategic implications: Prioritize PD‑(L)1 × VEGF assets and combinations; expand atypical‑EGFR and KRAS‑combo footprints; integrate companion diagnostics to capture RET/EGFR exon20ins opportunities. (read more)
Publications Related to Approved Drugs
Phase 3
lorlatinib
Lorlatinib versus crizotinib as first-line treatment for advanced ALK-positive non-small cell lung cancer: 7-year update from the phase 3 CROWN study. The 7-year update of the phase 3 CROWN study demonstrates unprecedented long-term efficacy for first-line lorlatinib in advanced ALK-positive NSCLC, with median progression-free survival still not reached and a remarkable 7-year PFS rate of 55%. These findings suggest that sustained disease control with lorlatinib can effectively transform advanced ALK-positive NSCLC into a chronic condition, supported by an absence of new intracranial progression events after 30 months. ()
Phase 1
amivantamab
Amivantamab in patients with advanced non-small cell lung cancer with MET exon 14 skipping mutation: Results from the CHRYSALIS study. Results from the CHRYSALIS study indicate that amivantamab provides durable anti-tumor activity and a manageable safety profile in patients with advanced NSCLC harboring MET exon 14 skipping mutations, achieving an overall response rate of 33% in previously treated patients and 50% in treatment-naïve patients. This highlights the EGFR-MET bispecific antibody as a promising, targeted therapeutic option for this specific molecular subset of NSCLC. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 1
Trastuzumab Deruxtecan in Patients With HER2-Overexpressing NSCLC: Results From Part 1 of the Open-Label, Multicenter, Phase 1b DESTINY-Lung03 Trial. Trastuzumab deruxtecan (T-DXd) monotherapy demonstrated promising clinical activity in pretreated patients with HER2-overexpressing non-small cell lung cancer, confirming its potential as a targeted therapy in this population. However, the combination of T-DXd with durvalumab and platinum chemotherapy resulted in dose-limiting toxicities, suggesting this specific combination is not viable for further development. ()
Phase 2
Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multicenter Basket Trial Analysis (NCI/SWOG S1609). Dual immune checkpoint inhibitor therapy with nivolumab and ipilimumab demonstrated comparable systemic efficacy and safety in patients with rare cancers, regardless of the presence of brain metastases. However, no intracranial complete or partial responses were observed, highlighting the need for further research into effective treatments for brain metastases in this population. ()
Phase 3
First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations. Sunvozertinib significantly prolonged progression-free survival and improved objective response rates compared to standard chemotherapy as a first-line treatment for advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations. These findings establish sunvozertinib as a highly effective and superior therapeutic option for this specific patient population. ()
Phase 2
Pembrolizumab with or without chemotherapy among older adults with advanced lung adenocarcinoma: a national, nonrandomized open-label phase II trial (Alliance A171901). Older adults with advanced lung adenocarcinoma receiving first-line pembrolizumab, with or without chemotherapy, experienced adverse event rates comparable to those seen in younger populations from registration trials. These findings support the inclusion of older, potentially frailer patients in immunotherapy trials and can guide shared decision-making in clinical practice. ()
PHASE1, PHASE2
HPK1 inhibitor NDI-101150 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: Phase 1/2 trial results. The novel HPK1 inhibitor NDI-101150 demonstrated a manageable safety profile and preliminary antitumor activity, including objective responses in clear cell renal cell carcinoma, both as a monotherapy and in combination with pembrolizumab. Pharmacodynamic analyses confirmed immune activation within the tumor microenvironment, supporting the continued clinical development of this targeted therapy. ()
Phase 2
Osimertinib plus selumetinib in patients with EGFR-mutated advanced NSCLC with BRAF alterations post-progression on first-line osimertinib: ORCHARD. The combination of osimertinib and the MEK inhibitor selumetinib showed minimal clinical activity in patients with EGFR-mutated advanced non-small cell lung cancer who developed BRAF alterations after progressing on first-line osimertinib. Given the low response rate and the frequency of adverse events, further evaluation of this specific combination is not warranted in this patient population. ()
Phase 1
Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors. The novel c-Met-targeting antibody-drug conjugate Temab-A demonstrated a manageable safety profile and promising antitumor activity in patients with heavily pretreated metastatic colorectal cancer. The established recommended phase II dose of 2.4 mg/kg once every 3 weeks supports further clinical evaluation of this agent in advanced solid tumors. ()
Phase 2
Osimertinib and Stereotactic Radiosurgery for Brain Metastases in EGFR-Mutated Lung Cancer: The STARLET Joint Analysis of OUTRUN and LUOSICNS Randomized Trials. The addition of upfront stereotactic radiosurgery to osimertinib did not significantly improve 12-month intracranial progression-free survival compared to osimertinib monotherapy in patients with EGFR-mutated non-small cell lung cancer and asymptomatic brain metastases. These findings support the use of osimertinib alone as an effective initial treatment strategy for patients with low-burden brain metastases. ()
Phase 1
Phase Ib of repotrectinib plus osimertinib in patients with EGFR-mutated advanced non-small cell lung cancer. The combination of repotrectinib and osimertinib demonstrated a manageable safety profile and promising intracranial activity in heavily pretreated patients with EGFR-mutated non-small cell lung cancer resistant to prior therapies. These findings suggest that this combination may offer a viable therapeutic strategy, particularly for patients with central nervous system involvement, warranting further investigation in biomarker-selected populations. ()
Phase 2
Plasmatic CXCL13 as a biomarker of primary resistance to immunotherapy and impaired peripheral immunity in non-small cell lung cancer. Elevated plasma levels of CXCL13 after the first cycle of immunotherapy are significantly associated with primary resistance and shorter survival in patients with non-small cell lung cancer. This suggests that monitoring CXCL13 could serve as a valuable prognostic biomarker to identify patients who may not benefit from standard immunotherapy and who exhibit an impaired peripheral immune profile. ()
PHASE1, PHASE2
Daraxonrasib in Previously Treated Advanced RAS-Mutated Pancreatic Cancer. The novel RAS(ON) multiselective inhibitor daraxonrasib demonstrated promising antitumor activity and a manageable safety profile in patients with previously treated, advanced RAS-mutated pancreatic ductal adenocarcinoma. These findings support the continued development of daraxonrasib, particularly at the selected phase 3 dose, as a targeted therapeutic option for this challenging malignancy. ()
Phase 3
TROPION-Lung14 study protocol: a phase III study of osimertinib in combination with datopotamab deruxtecan versus osimertinib alone as first-line treatment for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. The TROPION-Lung14 phase III trial is evaluating the efficacy and safety of combining osimertinib with the antibody-drug conjugate datopotamab deruxtecan as a first-line treatment for patients with EGFR-mutated advanced non-small cell lung cancer. This study aims to determine if this combination can overcome the limitations of osimertinib monotherapy and provide a superior therapeutic option for this patient population. ()
Phase 1
Phase III randomized studies of mevrometostat and enzalutamide in metastatic prostate cancer (MEVPRO-1 and MEVPRO-2): trial protocols. The MEVPRO-1 and MEVPRO-2 phase III trials are evaluating the efficacy and safety of combining the EZH2 inhibitor mevrometostat with enzalutamide in patients with metastatic castration-resistant prostate cancer. These studies aim to determine if this novel combination can significantly improve radiographic progression-free survival compared to standard therapies in both pretreated and treatment-naïve populations. ()
Phase 3
Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer. Adjuvant treatment with the selective RET inhibitor selpercatinib significantly prolonged event-free survival compared to placebo in patients with early-stage RET fusion-positive non-small-cell lung cancer following definitive therapy. These findings support the integration of targeted therapy into the curative-intent treatment paradigm for this specific molecular subgroup. ()
Phase 3
Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. First-line treatment with the antibody-drug conjugate sacituzumab tirumotecan plus pembrolizumab significantly prolonged progression-free survival compared to pembrolizumab alone in patients with PD-L1-positive advanced non-small-cell lung cancer without targetable genomic alterations. This combination therapy demonstrates the potential to redefine the standard of care for this patient population. ()
Phase 3
Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China. The combination of the bispecific antibody ivonescimab and chemotherapy significantly improved overall survival compared to tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small-cell lung cancer. This regimen offers a promising new therapeutic option with a manageable safety profile for this patient population. ()
Phase 2
Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: results from EV-202 cohort 9. The combination of enfortumab vedotin and pembrolizumab demonstrated promising clinical activity and a manageable safety profile as a first-line treatment for patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. These findings support further evaluation of this combination in this patient population. ()
Phase 2
Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Updated results confirm that subcutaneous and intravenous formulations of atezolizumab offer similar efficacy, safety, and immunogenicity in patients with non-small cell lung cancer. The subcutaneous route, which is preferred by patients, provides a convenient and well-tolerated alternative to intravenous administration without compromising clinical outcomes. ()
PHASE1, PHASE2
Deep learning and radiomics models in patients with advanced non-small cell lung cancer treated with immunotherapy combined with stereotactic radiotherapy. A deep learning model significantly outperformed a radiomics model in predicting per-lesion progressive disease in patients with advanced non-small cell lung cancer receiving immunotherapy. However, both models showed reduced performance upon external validation, highlighting the need for further research to improve the generalizability of quantitative imaging tools for clinical translation. ()
Phase 3
Nivolumab plus chemoradiotherapy followed by nivolumab with or without ipilimumab for untreated locally advanced stage III NSCLC: a randomized phase 3 trial. The addition of nivolumab, with or without ipilimumab, to concurrent chemoradiotherapy did not significantly improve progression-free or overall survival compared to standard consolidation with durvalumab in patients with unresectable stage III non-small cell lung cancer. Furthermore, the nivolumab-containing regimens were associated with increased rates of pneumonitis, underscoring the need for novel, more efficacious treatments in this setting. ()
Phase 2
Novel multiplex immunofluorescence-based tumor inflammation score provides apparent predictive biomarker in a phase I/II study of pembrolizumab with gemcitabine in patients with previously-treated advanced non-small cell lung cancer (NSCLC). A novel tumor inflammation score, integrating the spatial relationship between regulatory T cells and CD3 T cells, correlated significantly with disease response in patients with advanced NSCLC treated with pembrolizumab and gemcitabine. This suggests that characterizing cell-cell interactions in the tumor microenvironment may offer superior predictive power compared to standard biomarkers like PD-L1 expression. ()
Phase 2
Deep learning and radiomics models in patients with advanced non-small cell lung cancer treated with immunotherapy combined with stereotactic radiotherapy. A deep learning model significantly outperformed a radiomics model in predicting per-lesion progressive disease in patients with advanced non-small cell lung cancer receiving immunotherapy. However, both models showed reduced performance upon external validation, highlighting the need for further research to improve the generalizability of quantitative imaging tools for clinical translation. ()
Phase 3
Five-year outcomes of pembrolizumab versus chemotherapy in Chinese patients with non-small-cell lung cancer and programmed cell death ligand 1 tumor proportion score ≥1%: KEYNOTE-042 China study. Five-year follow-up data from the KEYNOTE-042 China study confirm that first-line pembrolizumab monotherapy provides a sustained overall survival benefit compared to chemotherapy in Chinese patients with PD-L1-positive advanced non-small-cell lung cancer. These long-term results, along with a manageable safety profile, reinforce pembrolizumab as a standard of care in this population. ()
Phase 2
Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis. A four-cycle perioperative regimen combining the PD-1 inhibitor serplulimab with taxane-carboplatin chemotherapy demonstrated high major pathological response and complete response rates in patients with resectable squamous non-small cell lung cancer. Additionally, circulating tumor DNA clearance strongly correlated with pathological complete response, suggesting its potential as a predictive biomarker for immunochemotherapy efficacy. ()
Phase 3
Five-year outcomes of pembrolizumab versus chemotherapy in Chinese patients with non-small-cell lung cancer and programmed cell death ligand 1 tumor proportion score ≥1%: KEYNOTE-042 China study. Five-year follow-up data from the KEYNOTE-042 China study confirm that first-line pembrolizumab monotherapy provides a sustained overall survival benefit compared to chemotherapy in Chinese patients with PD-L1-positive advanced non-small-cell lung cancer. These long-term results, along with a manageable safety profile, reinforce pembrolizumab as a standard of care in this population. ()
Phase 1
Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. The novel dual A2A/A2B adenosine receptor antagonist INCB106385 demonstrated high potency, favorable pharmacokinetics, and significant preclinical efficacy in overcoming adenosine-mediated immune suppression in the tumor microenvironment. These promising characteristics supported its advancement into Phase 1 clinical trials for cancer immunotherapy. ()
Phase 2
Osimertinib and Stereotactic Radiosurgery for Brain Metastases in EGFR-Mutated Lung Cancer: The STARLET Joint Analysis of OUTRUN and LUOSICNS Randomized Trials. The addition of upfront stereotactic radiosurgery to osimertinib did not significantly improve 12-month intracranial progression-free survival compared to osimertinib monotherapy in patients with EGFR-mutated non-small cell lung cancer and asymptomatic brain metastases. These findings support the use of osimertinib alone as an effective initial treatment strategy for patients with low-burden brain metastases. ()
PHASE1, PHASE2
Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer. Final data from the ARROW study confirm that the selective RET inhibitor pralsetinib delivers robust and durable responses, along with a manageable safety profile, in both treatment-naïve and previously treated patients with RET fusion-positive non-small cell lung cancer. These long-term results solidify pralsetinib as a highly effective targeted therapy for this specific molecular subgroup. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in non-small cell lung cancer updated from 2026-05-01 to 2026-05-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1--1--2
Not Yet Recruiting7414-4433
Recruiting2728662282153
Available-------
Approved for Marketing-------
Active, Not Recruiting181139120190
Completed224--19
Total55451234528287
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Dalpiciclib, Chidamide NCT05586841 COMPLETED Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study 2026-03-30
SRG-514 NCT06300411 COMPLETED A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery 2026-04-08
HRS-6209 Capsule (new formulation), HRS-6209 Capsule (old formulation) NCT07610148 NOT_YET_RECRUITING A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants 2026-06
Abemaciclib, BET Bromodomain Inhibitor ZEN-3694 NCT05372640 RECRUITING A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors 2026-06-01
Administation of ceralasertib in combination with durvalumab, Administration of ceralasertib and durvalumab, Administration of ceralasertib monotherapy, Administration of ceralasertib in combination with AZD5305, Administration of ceralasertib in combination with carboplatin, Administration of ceralasertib, Administration of ceralasertib and olaparib, Administration of ceralasertib in combination with olaparib NCT02264678 ACTIVE_NOT_RECRUITING A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. 2026-06-30
: Dendritic Cell Vaccine NCT05809752 ACTIVE_NOT_RECRUITING A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) 2026-08
Endoxifen Hydrochloride NCT03317405 ACTIVE_NOT_RECRUITING Phase I Trial of Endoxifen Gel Versus Placebo Gel in Women Undergoing Breast Surgery 2026-08-12
AVA6000 NCT04969835 RECRUITING A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours 2026-08-15
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
BB-1701 NCT06188559 COMPLETED An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer 2026-03-18
Patritumab deruxtecan NCT05865990 COMPLETED Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors 2026-04-03
Capecitabine, Trastuzumab, Vinorelbine NCT04296162 COMPLETED A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID) 2026-04-25
trifluridine/tipiracil NCT04489173 COMPLETED A Phase 2 Study of Trifluridine/Tipiracil in Patients With ER-positive, HER2-negative Advanced Breast Cancer That Previously Received Chemotherapy 2026-05-19
Fulvestrant, Letrozole, Exemestane, Denifanstat, Paclitaxel, Anastrozole, : Trastuzumab NCT03179904 ACTIVE_NOT_RECRUITING MC1633 Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy 2026-06-13
Paclitaxel NCT04090398 ACTIVE_NOT_RECRUITING Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer 2026-06-30
Halneuron, Halneuron (Open Label Extension) NCT06848348 RECRUITING A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain 2026-08
Abemaciclib NCT04305834 RECRUITING A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4/6 Inhibition 2026-08-21
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Goserelin Acetate, Exemestane, Goserelin, Entinostat NCT02115282 ACTIVE_NOT_RECRUITING A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer 2026-06-02
Carboplatin, Eribulin, Capecitabine, SKB264, Nab-paclitaxel, Paclitaxel NCT06279364 RECRUITING A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer 2026-07
Eribulin, Gemcitabine, Dato-DXd, Capecitabine, Vinorelbine NCT05104866 ACTIVE_NOT_RECRUITING A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) 2026-07-31
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Daflon (Diosmin and Hesperidin) NCT07588828 COMPLETED EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY 2026-04-15
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