Brief Summary

OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers. Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis \[TNM\] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC. The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

413

participants targeted

Target at P75+ for all trials

Timeline

14mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach

1 country

34 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

Study Progress83%

Dec 2020Jun 2027

First Submitted

Initial submission to the registry

November 13, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

December 18, 2020

Completed

9 months until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 4, 2025

Status Verified

August 1, 2025

Enrollment Period

6.5 years

First QC Date

November 13, 2020

Last Update Submit

August 1, 2025

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small-cell lung cancerUnresectableAdvanced stage

Outcome Measures

Primary Outcomes (3)

QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient)
Change in patient's QLQ-C30 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.
Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)
Change in patient's QLQ-LC13 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.
Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient)
Change in patient's EQ5D-5L during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.
Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned

Secondary Outcomes (18)

Baseline demographics
At Baseline
Tumor characteristics as defined by TNM stage
At Baseline
Tumor characteristics as defined by PD-L1 expression status
At Baseline
Tumor characteristics as defined by mutational status of driver genes
At Baseline
Time from diagnosis to treatment
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
+13 more secondary outcomes