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NCT04234607
A Randomized, Double-blind, Controlled, Multicenter Phase III Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer
Phase 3 trial testing TQB2450 in Extensive Small Cell Lung Cancer in 738 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 738 |
| Start date | 1 January 2020 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 26 locations across China |
Drugs / interventions tested
- TQB2450
- Anlotinib — full drug profile →
- Etoposide (etoposide) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- TQB2450(blank)
- Anlotinib(blank)
Conditions studied
- Extensive Small Cell Lung Cancer — all drugs for Extensive Small Cell Lung Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Extensive Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Progression free survival (PFS)
Time frame: up to 12 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. -
Overall survival (OS)
Time frame: up to 24 months
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Sponsor's own description
A randomized, double-blind, controlled, multicenter phase III study of TQB2450 or placebo combined with Anlotinib, etoposide and carboplatin versus Etoposide and Carboplatin in subjects with extensive small cell lung cancer. The primary outcome measures include PFS and OS. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1:1 to the experimental arms and the control arm.
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 2024.
Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450 -
Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial.
Cheng Y, Chen J, Zhang W, Xie C, et al · · 2024 · cited 91× · PMID 38992123 · DOI 10.1038/s41591-024-03132-1 -
Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538 -
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 -
Angiogenesis Inhibitors in Small Cell Lung Cancer.
Montanino A, Manzo A, Carillio G, Palumbo G, et al · · 2021 · cited 50× · PMID 34123809 · DOI 10.3389/fonc.2021.655316 -
Current and future therapies for small cell lung carcinoma.
Zhai X, Zhang Z, Chen Y, Wu Y, et al · · 2025 · cited 15× · PMID 40170056 · DOI 10.1186/s13045-025-01690-6 -
Targeted Therapies in Small Cell Lung Cancer: From Old Failures to Novel Therapeutic Strategies.
Cani M, Napoli VM, Garbo E, Ferrari G, et al · · 2023 · cited 11× · PMID 37240229 · DOI 10.3390/ijms24108883
Verify or expand the search:
- PubMed search for NCT04234607
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TQB2450
Trials testing the same drug.
- NCT06222944 — Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA · Phase 2 · not yet recruiting
- NCT06109402 — Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT05608785 — Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advan · Phase 1, PHASE2 · unknown
- NCT04895345 — A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Na · Phase 2 · completed
- NCT04623333 — A Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer · Phase 2 · unknown
Other recruiting trials for Extensive Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT06125041 — Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC · Phase 2 · recruiting
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed
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 NCT04234607 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 18 January 2020
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/NCT04234607.
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