NCT07037680 Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
| NCT ID | NCT07037680 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | JIANYANG WANG |
| Condition | Locally Advanced Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2024-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
jianyang wang
PRINCIPAL INVESTIGATOR
National Cancer Center
Frequently Asked Questions
Who can join the NCT07037680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07037680 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07037680 currently recruiting?
Yes, NCT07037680 is actively recruiting participants. Contact the research team at pkucell@163.com for enrollment information.
Where is the NCT07037680 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07037680 clinical trial?
NCT07037680 is sponsored by JIANYANG WANG. The principal investigator is jianyang wang at National Cancer Center. The trial plans to enroll 44 participants.
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