Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

Baseline demographics

Stage III unresectable NSCLC patients characteristics: baseline patient demographics at stage III NSCLC diagnosis, clinical, pathological and molecular characteristics (e.g. age, race, comorbidities)

Time frame: At Baseline

Tumor characteristics as defined by TNM stage

Characterize the stage III unresectable NSCLC patients by TNM stage according to the 8th TNM IASLC edition

Time frame: At Baseline

Tumor characteristics as defined by PD-L1 expression status

Characterize the stage III unresectable NSCLC patients by PD-L1 expression status (tumor propensity score)

Time frame: At Baseline

Tumor characteristics as defined by mutational status of driver genes

Characterize the stage III unresectable NSCLC patients by mutational status of driver genes (e.g. epidermal growth factor receptor \[EGFR\]) anaplastic lymphoma kinase \[ALK\], reactive oxygen species 1 \[ROS1\], human epidermal growth factor receptor 2 \[HER2\], PI3KCA, BRAF, MET, rearranged during transfection \[RET\], neurotrophic receptor tyrosine kinase \[NRTK\])

Time frame: At Baseline

Time from diagnosis to treatment

Time frame: From date of diagnosis until the date of first documented treatment or start date of best supportive care through study completion, up to 5 year

Modality of follow-up

Description of modality of follow-up (e.g. type of imagery used, frequency of medical visit)

Time frame: From date of diagnosis until the date of first documented progression or or date of death from any cause, whichever came first, assessed up to 5 years maximum

Median PFS

Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

Time frame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

Median time to progression

Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

Time frame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

Median OS (e.g. median PFS, median OS)

Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.

Time frame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months

Treatment characteristics

Describe the chemotherapy, radiation therapy and immunotherapy protocols used (e.g. dose, reduction, interruptions, duration)

Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum

Best response of treatment

Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum

Duration of response of treatment

Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum

Toxicity of treatment

limited to Cohorts 1, 2, 3 and 4 (restricted to significant AEs, which include but are not limited to: serious AEs \[SAEs\], AEs that led to treatment discontinuation, or any AEs ≥ grade 3 judged clinically significant by the Site Investigator)

Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum

Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision

Concordance between effective treatment compared to initial MDTB decision

Time frame: From date of first treatment administration up to end of study, assessed up to 5 years maximum

Type of progression (local, loco-regional, metastatic)

Time frame: At date of first documented progression, assessed up to 5 years maximum

Description of second line of treatment after disease progression

Treatment characteristics after disease progression including type of treatment (chemotherapy, radiotherapy, immunotherapy or Tyrosine-Kinase inhibitors), treatment duration, stop date of treatment and reason for end of treatment

Time frame: From date of first documented progression up to end of study, assessed up to 5 years maximum

Change in patients' socio-economic and occupational outcomes using unique self questionnaire

Change in patients' socio-economic and occupational outcomes during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study using a dedicated self questionnaire on socio-economic and occupational outcomes

Time frame: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum

Evaluate the cost-utility of the therapeutic strategy using Quality-Adjusted Life Years (QALYs)

Time frame: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum