Last reviewed · How we verify
NCT04425135
Phase II Single-arm Clinical Study of Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed +Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC
Phase 2 trial testing Camrelizumab in Lung Neoplasms in 59 participants. Status unknown.
1 January 2023
Quick facts
| Lead sponsor | The First Affiliated Hospital of Xiamen University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 59 |
| Start date | 1 July 2020 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 January 2025 |
Drugs / interventions tested
- Camrelizumab — full drug profile →
- Apatinib (Apatinib) — full drug profile →
- Pemetrixed — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Lung Neoplasms — all drugs for Lung Neoplasms →
Sponsor
The First Affiliated Hospital of Xiamen University
Who can join
Adults 18 to 75, any sex, with Lung Neoplasms. 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.
-
Objective response rate (ORR)
Time frame: up to approximately 1 year
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Sponsor's own description
This study is a phase II single-arm clinical study.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with apatinib mesylate and standard chemotherapy (pemetrexed plus carboplatin) in patients with advanced non-squamous and non-small cell lung cancer who have failed tyrosine kinase inhibitor therapy and are ALK-positive.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Narrative review: immunotherapy in anaplastic lymphoma kinase (ALK)+ lung cancer-current status and future directions.
Schenk EL. · · 2023 · cited 12× · PMID 36895933 · DOI 10.21037/tlcr-22-883 -
Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running?
Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2023 · cited 8× · PMID 37232842 · DOI 10.3390/curroncol30050384 -
Anaplastic lymphoma kinase-special immunity and immunotherapy.
Guo Y, Guo H, Zhang Y, Cui J. · · 2022 · cited 4× · PMID 35958559 · DOI 10.3389/fimmu.2022.908894
Verify or expand the search:
- PubMed search for NCT04425135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Camrelizumab
Trials testing the same drug.
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- NCT07521605 — Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer · Phase 2 · not yet recruiting
- NCT07466901 — A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Rad · NA · not yet recruiting
- NCT07527026 — A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant T · Phase 2 · recruiting
- NCT07266350 — A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for th · not yet recruiting
Other recruiting trials for Lung Neoplasms
Currently open trials in the same condition.
- NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult · Phase 2 · recruiting
- NCT07509333 — MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients · NA · recruiting
- NCT07109154 — DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First- · recruiting
- NCT06974604 — Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM · Phase 2 · recruiting
- NCT07165691 — TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics · NA · recruiting
Other The First Affiliated Hospital of Xiamen University trials
Trials by the same sponsor.
- NCT06875063 — GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL · Phase 1 · recruiting
- NCT07486492 — Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer · EARLY_PHASE1 · not yet recruiting
- NCT07458906 — DLL3-Targeted PET/CT in Neuroendocrine Carcinoma · NA · recruiting
- NCT07137052 — Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar · not yet recruiting
- NCT07189884 — Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy · Phase 1, PHASE2 · 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 NCT04425135 (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 The First Affiliated Hospital of Xiamen University
- Last refreshed: 8 June 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/NCT04425135.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing