Clinical trial · Interventional
Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）
A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy
NCT03743129CI-TRIAL-00067065ALTER-L029completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anlotinib
- description
- Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank).
- interventionNames
- Drug: Anlotinib
- type
- NO_INTERVENTION
- label
- Blank
- description
- No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Estimated to be from baseline up to 3 years
- description
- the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Age at least 18 years. * 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III). * 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. * 4.ECOG PS : 0 to 1. * 5.Estimated life expectancy of more than 12 weeks. Exclusion Criteria: * 1.Prior exposure to any anti-angiogenesis drugs. * 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis. * 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. * 4.Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy. * 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.
References
Publications (1)
- DERIVEDYang D, Li X, Xue X, Jiang L, Shi A, Zhao J. Anlotinib hydrochloride consolidation after concurrent chemoradiotherapy in stage III non-small-cell lung cancer: a truncated, randomized, multicenter, clinical study (ALTER-L029). Anticancer Drugs. 2024 Aug 1;35(7):680-685. doi: 10.1097/CAD.0000000000001617. Epub 2024 May 3. PMID 38718190