Combining TQB2450 and Anlotinib for Small Cell Lung Cancer Treatment

An Open, Single Arm, Single Center Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited Stage Small Cell Lung Cancer Without Progression After First-line Radiotherapy and Chemotherapy

This study is testing if combining two drugs, TQB2450 and anlotinib, can help people with limited-stage small cell lung cancer feel better after their initial treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Drugs / interventions: bevacizumab, arotinib, apatinib, chemotherapy, radiation, anlotinib
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05942508 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of TQB2450 in combination with anlotinib as a maintenance therapy for patients with limited-stage small cell lung cancer who have not progressed after initial chemoradiotherapy. The study aims to monitor the incidence and severity of both benign and serious adverse events, as well as any abnormal laboratory findings. Participants will receive these treatments to determine if they can improve outcomes for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with pathologically confirmed limited-stage small cell lung cancer who have not shown disease progression after first-line chemoradiotherapy.

Not a fit: Patients who have metastatic disease or require tumor resection during the study may not benefit from this treatment approach.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance therapy option for patients with limited-stage small cell lung cancer, potentially improving their survival and quality of life.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches in targeting small cell lung cancer have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
* Age: 18\~75 years old (when signing the informed consent form); ECOG PS score: 0-1 points; Expected survival beyond 6 months; body weight\> 40 kg;
* Patients with pathologically confirmed limited-stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG stage);
* Through the neck, chest, abdomen, pelvic enhanced CT and brain plain scan + enhanced MRI examination with diagnostic quality, there is no evidence of metastatic disease (PET-CT examination is recommended before starting radiotherapy and chemotherapy, if not performed before radiotherapy and chemotherapy PET-CT examination, bone scan examination should be performed; PET-CT examination must be performed during the screening period after chemoradiotherapy to exclude metastasis);
* It is expected that no tumor resection will be required during the study (patients who are not suitable for surgery or those who are unwilling to undergo surgery are acceptable);
* Radiotherapy technology adopts three-dimensional conformal radiotherapy, conformal intensity-modulated radiotherapy, tomographic radiation therapy and other precision radiotherapy technologies;
* Patients must achieve CR, PR or SD after receiving radical platinum-based CRT and cannot develop disease progression;
* Patients with at least one measurable lesion confirmed according to RECIST 1.1 criteria prior to chemoradiotherapy;

Exclusion Criteria:

* Complex small cell lung cancer confirmed by histopathology or cytopathology;
* Subjects with known central nervous system metastasis and/or cancerous meningitis;
* Malignant pleural effusion and pericardial effusion;
* Imaging shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
* Within 2 weeks before the start of the study treatment, he has received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug manual;
* Patients who have received immunomodulatory drugs within 30 days before starting treatment;
* Previously received anti PD-1, anti PD-L1, or anti PD-L2 drugs or medication targeting another stimulating or co inhibitory T cell receptor;
* Previous use of antivascular survival drugs（ bevacizumab, arotinib, apatinib ,ect);

Where this trial is running

Jinan, Shandong

• Cancer Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Jin ming Yu, postdoctor

Conditions Limited Stage Small Cell Lung Cancer; Not Progressed After First-line Chemoradiotherapy