Clinical trial · Interventional
Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial
NCT07037680CI-TRIAL-00091903recruitingPhase 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)
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Safety | — | UNRESOLVED | — |
| Thoracic Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy plus Anlotinib
- description
- Radiotherapy plus anlotinib in LA-NSCLC intolerable to cCRT
- interventionNames
- Drug: Anlotinib
Primary outcomes (1)
- measure
- 2-year progression-free survival (PFS)
- timeFrame
- From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months
Secondary outcomes (4)
- measure
- Overall Survival(OS)
- timeFrame
- From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patients with histologically or cytologically confirmed negative EGFR (including EGFR exon 19 deletion or L858R mutations) or ALK/ROS1-mutated locally advanced unresectable NSCLC were screened. Inclusion Criteria: 1. ≥18 years old with no restrictions on sex; 2. Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma; 3. Eastern cooperative oncology group (ECOG) score ≤2 was required; 4. Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression; 5. .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk; 6. No symptoms of hemoptysis; 7. Adequate hepatic and renal functions with a negative urine protein; 8. Expected survival of more than 6 months. Exclusion Criteria: 1. currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ; 2. previous malignancy within five years; 3. thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months; 4. uncontrolled or active pulmonary inflammation; 5. participated in other clinical trials; 6. Pregnant women.
References
Publications (17)
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