NCT03668496 is a Phase 3 clinical trial of SHR-1210 in Lung Cancer Squamous Cell, sponsored by Jiangsu HengRui Medicine Co., Ltd..

Who is sponsoring NCT03668496?

NCT03668496 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT03668496?

Interventions in NCT03668496: SHR-1210, The placebo.

What condition does NCT03668496 study?

NCT03668496 studies Lung Cancer Squamous Cell, Lung Cancer Stage IV, PD-1 Antibody, Chemotherapy Effect.

Is NCT03668496 still recruiting?

NCT03668496 is currently status unknown. Last updated 15 March 2021.

Last reviewed 2021-03-15 · How we verify

NCT03668496

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

Status unknown Phase 3 Last updated 15 March 2021

What this trial tests

Phase 3 trial testing SHR-1210 in Lung Cancer Squamous Cell in 390 participants. Status unknown.

Timeline

9 November 2018

Primary endpoint
6 November 2020

31 December 2021

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	390
Start date	9 November 2018
Primary completion	6 November 2020
Estimated completion	31 December 2021
Sites	53 locations across China

Drugs / interventions tested

SHR-1210 — full drug profile →
The placebo — full drug profile →

Conditions studied

Lung Cancer Squamous Cell — all drugs for Lung Cancer Squamous Cell →
Lung Cancer Stage IV — all drugs for Lung Cancer Stage IV →
PD-1 Antibody — all drugs for PD-1 Antibody →
Chemotherapy Effect — all drugs for Chemotherapy Effect →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Lung Cancer Squamous Cell or Lung Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Non-small cell lung cancer in China.
Chen P, Liu Y, Wen Y, Zhou C. · · 2022 · cited 479× · PMID 36075878 · DOI 10.1002/cac2.12359
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial.
Ren S, Chen J, Xu X, Jiang T, et al · · 2022 · cited 248× · PMID 34923163 · DOI 10.1016/j.jtho.2021.11.018
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
Current treatments for non-small cell lung cancer.
Guo Q, Liu L, Chen Z, Fan Y, et al · · 2022 · cited 75× · PMID 36033435 · DOI 10.3389/fonc.2022.945102
The evolving immuno-oncology landscape in advanced lung cancer: first-line treatment of non-small cell lung cancer.
Low JL, Walsh RJ, Ang Y, Chan G, et al · · 2019 · cited 45× · PMID 31497071 · DOI 10.1177/1758835919870360
Advances in molecular pathology and therapy of non-small cell lung cancer.
Huang Q, Li Y, Huang Y, Wu J, et al · · 2025 · cited 43× · PMID 40517166 · DOI 10.1038/s41392-025-02243-6
On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial.
Jiang T, Chen J, Xu X, Cheng Y, et al · · 2022 · cited 42× · PMID 34980131 · DOI 10.1186/s12943-021-01479-4

Verify or expand the search:

Other trials of SHR-1210

Trials testing the same drug.

NCT05799183 — A SHR-1210 BE Study on Healthy Subjects · Phase 1 · terminated
NCT04533490 — A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · unknown
NCT04680988 — A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer · Phase 2 · completed
NCT04790539 — a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer · Phase 2 · unknown
NCT04506242 — Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer · Phase 2 · unknown

Other recruiting trials for Lung Cancer Squamous Cell

Currently open trials in the same condition.

NCT06772454 — To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand · recruiting

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03668496 (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: 15 March 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/NCT03668496.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing