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NCT03778138: ALTER-L025
Study of Anlotinib Combined With Pemetrexed in Patients With Advanced Nonsquamous NSCLC
Phase 2 trial testing Anlotinib plus Pemetrexed in Non-squamous Cell Non-Small Cell Lung Cancer in 51 participants. Status unknown.
31 December 2019
Quick facts
| Lead sponsor | Henan Provincial People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 January 2019 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib plus Pemetrexed — full drug profile →
Conditions studied
- Non-squamous Cell Non-Small Cell Lung Cancer — all drugs for Non-squamous Cell Non-Small Cell Lung Cancer →
Sponsor
Henan Provincial People's Hospital
Who can join
Adults 18 to 75, any sex, with Non-squamous Cell Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent years, with the progress in the treatment field, NSCLC has become the most successful cancer species in precision medicine. Patients with positive driving genes such as EGFR, ALK, ROS1, BRAF and so on have clearly targeted drugs, which bring survival benefits to patients.However, about 50% of patients still lack a clear driving gene target, which has become the focus of current research.In the field of wild-type NSCLC with negative driver genes, the classic first-line treatment regimen is the two-drug regimen containing platinum.he phase II clinical study of pemetrexed in the second-line treatment of advanced non-small cell lung cancer patients with pemetrexed versus carboplatin pemetrexed showed that the median PFS time in the pemetrexed group was 3.5 months. Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development.In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. The efficacy and safety of anrotinib combined with pemetrexed in the second-line treatment of advanced non-squamous and non-small cell patients deserve further exploration.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03778138
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Anlotinib plus Pemetrexed
Trials testing the same drug.
- NCT03768037 — Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC · Phase 4 · unknown
Other Henan Provincial People's Hospital 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 NCT03778138 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henan Provincial People's Hospital
- Last refreshed: 19 December 2018
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/NCT03778138.
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