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NCT04316364
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
Phase 3 trial testing SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin in Non-Small-Cell Lung Cancer in 537 participants. Currently enrolling.
15 April 2023
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 537 |
| Start date | 14 July 2020 |
| Primary completion | 15 April 2023 |
| Estimated completion | 15 December 2026 |
| Sites | 7 locations across China |
Drugs / interventions tested
- SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin — full drug profile →
- SHR-1316、Chemotherapeutic — full drug profile →
- Placebo、Chemotherapeutic — full drug profile →
Conditions studied
- Non-Small-Cell Lung Cancer — all drugs for Non-Small-Cell Lung Cancer →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Non-Small-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476 -
Antibodies to watch in 2023.
Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410 -
Signaling pathways and targeted therapies in lung squamous cell carcinoma: mechanisms and clinical trials.
Niu Z, Jin R, Zhang Y, Li H. · · 2022 · cited 127× · PMID 36198685 · DOI 10.1038/s41392-022-01200-x -
Antibodies to watch in 2024.
Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450 -
Neoadjuvant immunotherapy for non-small cell lung cancer: State of the art.
Kang J, Zhang C, Zhong WZ. · · 2021 · cited 121× · PMID 33689225 · DOI 10.1002/cac2.12153 -
Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy.
Boyero L, Sánchez-Gastaldo A, Alonso M, Noguera-Uclés JF, et al · · 2020 · cited 78× · PMID 33322522 · DOI 10.3390/cancers12123729 -
Trial watch: chemotherapy-induced immunogenic cell death in oncology.
Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591 -
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
Verify or expand the search:
- PubMed search for NCT04316364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
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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 NCT04316364 (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 Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 4 November 2021
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/NCT04316364.
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