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SCLCJanuary 2026
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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 small cell lung cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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small cell lung cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • The FDA’s October 2025 approval of lurbinectedin plus atezolizumab as first‑line maintenance for extensive‑stage SCLC was underscored in January 2026 regulatory reviews as a key shift in the frontline continuum.
    • The FDA’s 2025 conversion of tarlatamab‑dlle from accelerated to traditional approval consolidated DLL3 engagement as a pillar beyond chemotherapy for post‑platinum ES‑SCLC.
  • Important Drug Publication Updates
    • An FDA approval summary reported tarlatamab achieved a 40% overall response rate and 9.7‑month median duration of response in post‑platinum ES‑SCLC (DeLLphi‑301), with boxed warnings for serious cytokine release syndrome and ICANS guiding monitoring and mitigation.
  • Key Clinical Development Updates
    • Phase 3 DeLLphi‑305/306 were identified as the backbone for tarlatamab life‑cycle regulatory strategy, and 2026 readouts from biomarker‑guided DLL3 programs plus ADC datasets are expected to refine sequencing and combination approaches.
  • Important Clinical Trial Publications
    • NRG Oncology/Alliance LU005 showed no overall or progression‑free survival benefit from adding concurrent and adjuvant atezolizumab to chemoradiation in limited‑stage SCLC versus chemoradiation alone.
    • The phase II DDRiver SCLC 250 study of berzosertib plus topotecan in relapsed platinum‑resistant SCLC was terminated for futility with a 5.5% objective response rate, indicating no added benefit over topotecan monotherapy.
  • Key Conference Updates
    • January 2026 expert forums highlighted DLL3‑directed T‑cell engagers—particularly tarlatamab—with manageable early‑onset CRS via step‑up dosing and emerging CTC‑based DLL3 assays demonstrating high specificity to guide patient selection.
    • ADC momentum featured ifinatamab deruxtecan’s 46.2% intracranial response in patients with brain metastases, spotlighting CNS‑active options for relapsed ES‑SCLC under global evaluation.
  • Emerging Themes & Macro‑Trends
    • Health‑system strategy is pivoting to implement DLL3 testing workflows—including CTC‑based assays—and to build CRS/ICANS management infrastructure to support scaling of DLL3‑directed T‑cell engagers.
    • Payer cost‑effectiveness analyses are poised to shape coverage and uptake of durvalumab consolidation in LS‑SCLC, prompting pathway updates to align clinical practice with reimbursement policy.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-01-01 and 2026-01-31 about small cell lung cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Peer‑reviewed update (Antibodies, Jan 4, 2026) reviews recent U.S. FDA actions in SCLC, noting Amgen’s Imdelltra (tarlatamab‑dlle) received accelerated approval in 2024 and was converted to traditional approval in 2025, and highlighting the October 2025 FDA approval of Jazz/Roche’s Zepzelca (lurbinectedin) + Tecentriq (atezolizumab) as first‑line maintenance in ES‑SCLC; the article also summarizes ongoing phase 3 DeLLphi‑305/306 studies that support life‑cycle regulatory strategies for tarlatamab.¹ (read more)
  • AACR’s FDA approvals recap (Jan 6, 2026) catalogs late‑2025 lung cancer approvals, including the FDA approval of lurbinectedin + atezolizumab maintenance for ES‑SCLC (Jazz Pharmaceuticals/Genentech) and the FDA’s conversion of Amgen’s Imdelltra (tarlatamab‑dlle) from accelerated to traditional approval, placing these SCLC milestones in the broader Q4 2025 regulatory context.² (read more)
Publications Related to Approved Drugs
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 for adults with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, based on the DeLLphi-301 trial demonstrating an overall response rate of 40% and a median duration of response of 9.7 months. Clinicians should note the boxed warning for serious cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), when managing patients on this therapy.
New Publications Related to Drugs in Clinical Trial Development
Phase 3
Chemoradiation ± Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005. This Phase 3 trial evaluated the addition of concurrent and adjuvant atezolizumab to standard chemoradiation in patients with limited-stage small cell lung cancer (LS-SCLC), but found no significant improvement in overall survival or progression-free survival compared to chemoradiation alone. The results suggest that while the combination was safe, adding PD-L1 inhibition in this specific concurrent and adjuvant setting does not enhance therapeutic efficacy for LS-SCLC.
Phase 3
Tislelizumab plus platinum and etoposide versus placebo plus platinum and etoposide as first-line treatment for extensive-stage small-cell lung cancer: patient-reported outcomes in the RATIONALE-312 trial. Analysis of patient-reported outcomes from this Phase 3 study demonstrates that first-line tislelizumab combined with chemotherapy maintained or improved health-related quality of life and alleviated symptoms such as coughing and chest pain compared to chemotherapy alone. These findings support the clinical value of this regimen for extensive-stage SCLC, complementing the survival benefits previously established in the trial.
Phase 2
A phase II, multicenter, open-label, single-arm study of berzosertib plus topotecan in patients with relapsed platinum-resistant small-cell lung cancer (DDRiver SCLC 250). This Phase 2 study investigating the ATR inhibitor berzosertib in combination with topotecan for relapsed platinum-resistant SCLC was terminated early due to futility, demonstrating a low objective response rate of 5.5%. The data indicate that this combination offers no additional clinical benefit over topotecan monotherapy in this difficult-to-treat patient population.
Conference
Major Conference Updates
Conference Information
  • 23rd Annual Winter Lung Cancer Conference®, Miami Beach, Florida, January 23–25, 2026; 2026 West Oncology Conference, Memphis, Tennessee, January 31–February 1, 2026. (read more)
  • Overall sentiment: January discussions emphasized DLL3-directed T-cell engagers and ADCs as the main innovation engines in SCLC, while early-setting IO strategies are being refined by new evidence and cost-effectiveness analyses. (read more)
  • Theme 1: DLL3 T-cell Engagers Move Toward Biomarker-Guided Integration
    • Significance: Rapid clinical maturation of tarlatamab-dlle (IMDELLTRA) positions DLL3 engagement as a pillar beyond chemotherapy in post-platinum ES-SCLC; growing focus on selecting likely responders. (read more)
    • Mechanism insights / clinical impact: BiTE mechanism (CD3×DLL3) with early-onset, mostly mild CRS manageable via step-up dosing/shortened monitoring; CTC-based DLL3 assessment showed high specificity for benefit, supporting practical biomarkerization. (read more)
    • Patient populations affected: ES-SCLC after platinum failure (current label) with exploration of earlier maintenance/frontline settings under discussion in expert forums. (read more)
  • Theme 2: ADC Renaissance with CNS-Relevant Activity
    • Significance: ADCs are re-emerging as credible options in relapsed SCLC; CNS activity directly addresses a high-morbidity need. (read more)
    • Mechanism insights / clinical impact: Ifinatamab deruxtecan (I-DXd; B7-H3 ADC) in IDeate-Lung01 achieved 46.2% intracranial response in patients with brain metastases—highlighting targeted payload delivery while sparing normal tissue. (read more)
    • Patient populations affected: Relapsed ES-SCLC, particularly those with brain metastases or B7-H3–expressing tumors; global applicability as trials broaden enrollment. (read more)
  • Theme 3: Early-Setting IO Recalibration (Consolidation vs Concurrent)
    • Significance: Divergent data are resetting strategy in limited-stage SCLC—affirming consolidation while discouraging concurrent addition of PD-L1 to CRT. (read more)
    • Mechanism insights / clinical impact: ADRIATIC’s durvalumab consolidation improved OS/PFS but payer analyses raise affordability concerns; LU005 showed no OS benefit with concurrent/adjuvant atezolizumab and higher grade ≥3 immune AEs, steering clinicians toward consolidation paradigms and vigilant toxicity management. (read more)
    • Patient populations affected: LS-SCLC post-CRT candidates across U.S. centers; access dynamics may vary by payer due to ICER-like assessments. (read more)
  • Significance
    • Expected clinical or translational readouts: Continued DLL3 programs (biomarker-driven selection via CTCs) and ADC datasets are poised to refine sequencing and combination strategies in 2026. (read more)
    • Regulatory or policy implications: Cost-effectiveness analyses may shape durvalumab consolidation uptake and coverage; institutions should prepare pathway updates aligned with payer policy. (read more)
    • Potential shifts in standard of care: Growing adoption of tarlatamab-dlle after platinum failure; mounting enthusiasm for ADCs in CNS-involved relapse; consolidation IO favored over concurrent PD-L1 with CRT. (read more)
    • Strategic implications: Prioritize DLL3 testing workflows (including CTC-based assays), build CRS/ICANS management infrastructure for TCEs, and consider trial participation for ADCs to capture CNS benefit niches. (read more)
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in 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 Recruiting682225144
Recruiting5339535391190
Available-------
Approved for Marketing-------
Active, Not Recruiting282131421-105
Completed2-4-3-9
Total896811111682349
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
SNB-101 NCT04640480 COMPLETED A Phase I, Open-Label, Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Infused SNB-101(as SN-38) in Patients With Advanced Solid Tumors 2026-01-05
Carboplatin, Etoposide, Debio 0123 NCT05815160 ACTIVE_NOT_RECRUITING A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy 2026-02
Fluorouracil, Leucovorin, Oxaliplatin, AB598, Zimberelimab 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
PF-08046037, sasanlimab 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
: LY2875358, Erlotinib 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
Sotorasib, Durvalumab 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
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
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
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
Erlotinib 150/100 mg, Placebo Gefitinib 250 mg, Gefitinib 250 mg, AZD9291 80 mg/40 mg + placebo, Placebo Erlotinib 150/100mg, Placebo AZD9291 80 mg/ 40 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
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Pemetrexed, Gemcitabine, Carboplatin, Cisplatin, 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.
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