Anlotinib in Cross-line Treatment of NSCLC and SCLC

Starting soon

Conditions studied: NSCLC (Advanced Non-small Cell Lung Cancer), SCLC, Extensive Stage

In brief

Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer. This study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.

Key facts

Study ID

NCT07400575

Run by

Henan Cancer Hospital

People needed

350

Starts

2026-02-01

Expected to finish

2027-12-31

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• From October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:
• Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.
• Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.
• Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.

You may not qualify if…

• From October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:
• Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.
• Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.
• Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.
• Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.

Full record on ClinicalTrials.gov

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