Combination treatment for stage III non-small cell lung cancer before surgery

Neoadjuvant Durvalumab/Anlotinib /Chemotherapy Plus Curative Resection in Stage III Non-Small-Cell Lung Cancer : A Single-arm Phase II Study

This study is testing a new combination of medications and chemotherapy before surgery to see if it helps people with stage III non-small cell lung cancer do better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: prednisone, Durvalumab, Anlotinib, Chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04762030 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a combination treatment involving Durvalumab, Anlotinib, and chemotherapy prior to surgical resection in patients with resectable stage III non-small cell lung cancer. Participants will receive these treatments in a single-arm phase II setting, aiming to improve outcomes for this challenging cancer stage. The study will assess the response to the treatment regimen and its impact on surgical success.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a pathologically confirmed diagnosis of resectable stage III non-small cell lung cancer.

Not a fit: Patients with non-resectable tumors or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes and survival rates for patients with stage III non-small cell lung cancer.

How similar studies have performed: While there have been studies exploring similar combination therapies, this specific approach is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

* Written informed consent provided.
* Males or females aged ≥18 years.
* Pathologically diagnosed of non-small cell lung cancer.
* Diagnosed as stage III.
* Tumor should be considered resectable before study entry by a multidisciplinary team.
* ECOG (Performance status) 0-1.
* Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to treatment.

  i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits.
* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
* All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
* Patient capable of proper therapeutic compliance and accessible for correct follow-up.
* Measurable or evaluable disease (according to RECIST 1.1 criteria).

Exclusion Criteria:

* All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
* central type, with empty lung squamous cell carcinoma or non-small cell lung cancer with hemoptysis (\>50 mL/day).
* Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
* Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy.
* Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
* Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
* Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
* Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
* Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* Patients with history of allergy to study drug components excipients. Women who are pregnant or in the period of breastfeeding.
* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

Where this trial is running

Shanghai, Shanghai

• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Junqi Wu

Conditions Non Small Cell Lung Cancer