Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Dec 17, 2024

Keywords

ClinConnect Summary

The SAVED LUNG study is a clinical trial designed to explore the safety and feasibility of either observing patients or performing standard surgery for those with operable Stage II-III non-small cell lung cancer (NSCLC) who have shown a complete response to initial treatment with chemotherapy and immunotherapy. In this study, participants will be randomly assigned to either continue observation or undergo surgery after confirming their disease status. The main goals of the trial are to ensure that both approaches are safe and to see how well they work over time.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of NSCLC that is treatable with the study's therapies. They should also have a specific protein level (PD-L1) in their tumor that is higher than 50%. Participants will need to meet certain health criteria and provide informed consent. Throughout the trial, participants will be closely monitored, and there will be opportunities to analyze their treatment response through various tests. It’s important to note that the study is not yet recruiting participants, so there will be more details to come as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \> 18 years of age
• • The participant has provided documented informed consent for the trial.
• • Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg/kg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.
• • PD-L1 tumor proportion score \>50%
• • Has no history of immunodeficiency, HBV, HCV, HIV.
• * For female participants:
• • 1. Has no active pregnancy (Refer to "Female participants").
• • 2. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
• • 3. A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.
• • 4. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• • Has adequate hematological, renal and hepatic function per Investigator discretion required for platinum-doublet chemotherapy plus immunotherapy.
• • Has signed the written consent.
• Exclusion Criteria:
• * Has one of the following tumor locations/types:
• • 1. NSCLC involving the superior sulcus
• • 2. Large cell neuro-endocrine cancer (LCNEC)
• • 3. Sarcomatoid tumor
• • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• • Has an active infection requiring systemic therapy.
• • Has had an allogenic tissue/solid organ transplant.
• • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
• • Has a known additional malignancy that is progressing or requires active treatment within the past (5 years). Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.