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NCT04728724
Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer
Phase 2 trial testing Sintilimab in Non-small Cell Lung Cancer Stage III in 100 participants. Currently enrolling.
15 September 2023
Quick facts
| Lead sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 10 September 2022 |
| Primary completion | 15 September 2023 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
- Chemotherapy (chemotherapy) — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer Stage III — all drugs for Non-small Cell Lung Cancer Stage III →
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Who can join
Adults 18 to 75, any sex, with Non-small Cell Lung Cancer Stage III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting nucleotide metabolism: a promising approach to enhance cancer immunotherapy.
Wu HL, Gong Y, Ji P, Xie YF, et al · · 2022 · cited 123× · PMID 35477416 · DOI 10.1186/s13045-022-01263-x -
Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7 -
Neoadjuvant treatment in non-small cell lung cancer: New perspectives with the incorporation of immunotherapy.
Aguado C, Chara L, Antoñanzas M, Matilla Gonzalez JM, et al · · 2022 · cited 23× · PMID 35662985 · DOI 10.5306/wjco.v13.i5.314 -
Conversion therapy with immunotherapy plus chemotherapy achieves a pathological complete response in stage IIIC NSCLC.
Fu Y, Duan W, Xu R, Chen J. · · 2023 · cited 1× · PMID 38022567 · DOI 10.3389/fimmu.2023.1268153 -
Progress in perioperative immunotherapy for lung cancer and analysis of therapy (Review).
Ma X, Li G, Li H, Li L, et al · · 2026 · PMID 41560977 · DOI 10.3892/ol.2026.15453 -
Efficiency and safety of sintilimab-based induction therapy in potentially resectable stage III non-small cell lung cancer (LungMate-009): an open-label, phase 2 trial.
Ge T, Zhang H, Zhu X, Teng M, et al · · 2025 · PMID 41477564 · DOI 10.1016/j.eclinm.2025.103669
Verify or expand the search:
- PubMed search for NCT04728724
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sintilimab
Trials testing the same drug.
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- NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
- NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
Other recruiting trials for Non-small Cell Lung Cancer Stage III
Currently open trials in the same condition.
- NCT06908070 — Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab · Phase 4 · recruiting
- NCT06634199 — Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients · recruiting
- NCT05557552 — Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer · NA · recruiting
- NCT05398094 — Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy · Phase 2 · recruiting
- NCT04685070 — Neoadjuvant HS-10296 (Almonertinib) Therapy for Potential Resectable Stage III EGFR Mutation-Positive Non-small Cell Lun · Phase 2 · active not recruiting
Other Shanghai Pulmonary Hospital, Shanghai, China trials
Trials by the same sponsor.
- NCT07469488 — A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-M · Phase 4 · not yet recruiting
- NCT07494591 — TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery · NA · not yet recruiting
- NCT07517640 — Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial · Phase 2 · not yet recruiting
- NCT07393438 — Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS) · Phase 2 · not yet recruiting
- NCT07375979 — A Multi-modal Integrating Imaging and Cell-free DNA Methylation in Lung Cancer Early Detection (CMe-Lung): a Multi-cente · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04728724 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Pulmonary Hospital, Shanghai, China
- Last refreshed: 13 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04728724.
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