Durvalumab+ Anlotinib + Standard Chemotherapy in First-line Treatment of Extensive Small-cell Lung Cancer: a Single-arm Phase II Clinical Study

Plain English Summary

Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer is a Phase 2 clinical trial sponsored by Henan Cancer Hospital studying SCLC, Extensive Stage. This trial tests a combination of drugs (anlotinib, durvalumab, and standard chemotherapy) for a specific type of lung cancer. It is for patients with extensive-stage small-cell lung cancer (SCLC) who have not received prior treatment. Participants will receive the study drugs, and their health will be closely monitored. Standard chemotherapy alone is the current usual treatment for this condition. The trial aims to enroll 34 participants.

Official Summary

Small Cell Lung cancer (SCLC) is a highly aggressive tumor that accounts for about 15 percent of all lung cancer cases. SCLC disease progresses rapidly, and about 2/3 of the patients have extensive stage (ES-SCLC) at the time of diagnosis, with extremely poor prognosis. However, the overall survival (OS) of ES-SCLC patients was not significantly prolonged, with platinum combined with etoposide chemotherapy as the standard treatment. In recent years, the emergence of Immune checkpoint inhibitor (ICI) has made the treatment of ES-SCLC appear at the dawn. In Impower133 study, Atezolizumab combined with chemotherapy significantly prolonged OS(median OS 12.3 months vs 10.3 months, HR=0.70, 95%CI 0.54-0.91, P = 0.007). Durvalumab combined with chemotherapy (CASPIAN study) is the first study in 20 years in which the total survival time of ES-SCLC treated by first-line therapy is 13 months, and there is no significant increase in adverse reactions compared with chemotherapy. Therefore, in 2019, NCCN also recommended Atezolizumab or Durvalumab+ EC regimens as a category 1 preferred option for first-line treatment of ES-SCLC.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients must be diagnosed with extensive-stage small-cell lung cancer. They should be between 18 and 74 years old and in good general health (ECOG 0-1). Patients with active brain metastases, recent chest radiation, or certain other medical conditions may not be eligible. This trial is studying SCLC, Extensive Stage, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome, Progression-Free Survival (PFS), measures how long patients live without their cancer getting worse, indicating how well the treatment controls the disease. The specific primary outcome measures are: Progression Free Survival (PFS) (Assessed up to 60 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to find a more effective first-line treatment for extensive-stage small-cell lung cancer, a very aggressive form of the disease with limited treatment options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets SCLC, Extensive Stage, where improved treatment options are needed.

Investor Insight

This trial explores a novel combination therapy for a difficult-to-treat cancer, potentially offering a new option in a market with significant unmet needs. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this combination therapy is suitable for your specific situation and if you meet all the eligibility requirements. Participation involves receiving the study medications and regular medical check-ups, including scans to monitor your cancer. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 34 participants

Interventions

• DRUG: Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer — This trial is single-armed IIb stage clinical trial to study the efficacy and safety of Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer . We use the outcome of CASPIAN trial as control group. The primary endpoint is ORR according to the RECIST 1.1, and secondary endpoints are PFS, OS, satety and life quality.

Primary Outcomes

• Progression Free Survival (PFS) (Assessed up to 60 months)

Secondary Outcomes

• Objective Response Rate (ORR ) (From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.)
• Disease Control Rate (DCR) (From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.)
• overall survival (OS ) (From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months)
• Time To Response (TTR) (Up to 60 months)
• Duration of response (DoR) (Up to 60 month)

Full Eligibility Criteria

Inclusion Criteria:

* Histologically confirmed primary treatment of ES-SCLC (small cell lung cancer) in male or female patients aged ≥18 and \<75 years.
* The ECOG energy status is 0 or 1.
* Appropriate hematologic and terminal organ functions.

Exclusion Criteria:

* Prior to systemic treatment, the patient had a history of chest radiation therapy or planned to undergo intensive chest radiation therapy.
* Spinal cord compression not explicitly treated by surgery and/or radiation, or previously diagnosed and treated, with no evidence of clinical stabilization of \>2 weeks prior to randomization. Active brain metastases (stable brain metastases may be admitted after treatment) occurred within one month prior to enrollment.
* Uncontrolled or symptomatic hypercalcemia, active tuberculosis, major cardiovascular disease.
* A history of autoimmune diseases, idiopathic pulmonary fibrosis, organized pneumonia, HIV positive, active hepatitis B, radiographic findings of tumor infiltration of the large vessels in the chest and significant pulmonary cavitation lesions, a previous history of hypertensive crisis or hypertensive encephalopathy.
* History of hemoptysis within 1 month prior to randomization (≥0.5 TSP of bright red blood per episode).
* Major surgery within 28 days or needle core biopsy or other minor surgical procedures within 7 days.

Trial Locations

• Sixth People's Hospital of Luoyang, Luoyang, Henan, China
• Henan Tumor Hospital, Zhengzhou, Henan, China

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Extensive Stage Lung Cancer
• Lung Cancer
• Chemotherapy
• Immunotherapy
• Targeted Therapy
• Oncology
• Cancer Treatment
• Thoracic Oncology
• Malignant Neoplasms of the Respiratory Tract

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