Radiation plus anlotinib for locally advanced non-small cell lung cancer when concurrent chemoradiotherapy isn't possible

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

This phase II trial will see if adding the anti-angiogenic drug anlotinib during radiotherapy improves two-year progression-free survival for patients with unresectable, EGFR-negative locally advanced non-small cell lung cancer who cannot tolerate concurrent chemoradiotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy, Anlotinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07037680 on ClinicalTrials.gov

What this trial studies

This single-arm phase II study enrolls patients with unresectable, locally advanced NSCLC who received sequential chemoradiotherapy because they could not tolerate concurrent chemoradiotherapy, and gives oral anlotinib during the course of thoracic radiotherapy. The trial aims to raise the 2-year progression-free survival rate from an expected 35% with standard sequential therapy to 50%, with a planned accrual of 44 patients. Safety and tolerability of the combination are monitored alongside efficacy endpoints. The study is conducted at the Cancer Institute and Hospital in Beijing with predefined eligibility criteria including performance status, organ function, and absence of tumor cavitation or hemoptysis.

Who should consider this trial

Good fit: Adults with unresectable, locally advanced NSCLC who lack sensitizing EGFR mutations (or have ALK/ROS1 alterations), cannot receive concurrent chemoradiotherapy, have ECOG ≤2, and adequate organ function are the intended candidates.

Not a fit: Patients with tumor cavitation or hemoptysis, significant proteinuria or impaired hepatic/renal function, current treatment for other active malignancies, or very limited life expectancy were excluded and are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, adding anlotinib could increase the share of patients who remain free of disease progression at two years compared with sequential chemoradiotherapy alone.

How similar studies have performed: Anti-angiogenic agents have produced benefits in some lung cancer combinations, but the specific pairing of anlotinib with thoracic radiotherapy in this patient group is relatively novel with limited prior phase II data.

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.

Where this trial is running

Beijing, Beijing Municipality

• Department of Radiation Oncology,Cancer Institute and Hospital,Chinese — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: jianyang wang — National Cancer Center
• Study coordinator: jianyang wang, MD

Conditions: Locally Advanced Non-Small Cell Lung Cancer, Thoracic Radiotherapy, Safety, thoracic radiotherapy, non-small cell lung carcinoma, locally advanced, safety, Anlotinib