Prospective Evaluation of Immunological, Molecular-genetic, Image-based and Microbial Analyzes to Characterize Tumor Response and Control in Patients With Inoperable Stage III NSCLC Treated With Chemoradiotherapy Followed by Consolidation Therapy With Durvalumab

Launched by LMU KLINIKUM · Aug 24, 2021

Keywords

ClinConnect Summary

The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) according to the current European Medicines Agency (EMA) approval.

The oncological treatment is carried out according to the international standards of radiation oncology/medical oncology. These are implemented by the department of radiation oncology at the University Hospital Munich (LMU) in their SOPs. Therefore, all patients will be treated with concurrent platinum-based chemoradiotherapy ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient age ≥ 18 years
• • Histologically/cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC)
• • Patients with non-operable NSCLC in tumor stage III A/B/C after UICC 8
• • Eligible for platinum-based concurrent chemoradiotherapy followed by durvalumab maintenance treatment
• • No invasive carcinoma in the last five years.
• • ECOG Performance Status 0-2
• • Lung function parameters (before or after bronchodilation): FEV1 ≥ 1.0 L and/or DLCO-SB ≥ 40%
• • A maximum of two cycles of induction chemotherapy are permissible before start of chemoradiotherapy
• Exclusion Criteria:
• • Simultaneous participation in another clinical trial
• • Mixed histology of small-cell and non-small-cell lung cancer
• • Brain metastases confirmed by a contrast enhanced cMRI
• • Prior receipt of an immunotherapy or investigational medicinal product
• • Previous exposure to an anti-PD-1 or anti-PD-L1 antibody
• • Pneumonitis ≥ Grade 2 as a result of prior radio-/chemoradiotherapy
• • Patients with a non-active disease in the last 5 years can be included, but only after consultation with the responsible investigator of the study or his representative
• • Primary immunodeficiencies in previous history
• • Prior Interstitial lung disease (ILD)
• • Prior autoimmune disease
• • Previous organ transplantation with subsequent therapeutic immunosuppression