Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
Treatment choice
Brief summary
The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years. New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics. The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.
Detailed description
This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV non small cell lung cancer (NSCLC) selected for systemic treatment or best supportive care will be included in the trial at the time the patient signed the informed consent form (ICF). Patients that were selected for systemic treatment, should have received at least their first dose and a maximum of one cycle of the same treatment. The pneumo-oncologist that treats the patient will fill in the CRF, indicating the systemic treatment option and the link with the variable categories that impacted the choice for a systemic treatment option.
Interventions
OTHERNone - Common practice
None - Common practice
Sponsors
MSD Belgium BVBA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have voluntarily agreed to participate by giving written informed consent/assent for the trial. * Have a histologically or cytologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) on first-line (1L) systemic treatment. * Have received at least their first dose of the selected systemic treatment and a maximum of 1 cycle of the same treatment. Patients that were selected to receive best supportive care will not have to comply to this inclusion criterion. * Be ≥ 18 years of age on day of signing informed consent.
Exclusion criteria
* Has received prior systemic treatment for their metastatic non-small cell lung cancer (NSCLC) before the first dose of trial treatment. However, subjects who received adjuvant or neoadjuvant therapy during an earlier stage of their disease, but evolved to stage IV, are eligible. * Tyrosine kinase inhibitor (TKI) selected as first-line systemic treatment. * Is participating in an interventional trial or medical need program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Study Outcome is Defined as the Systemic Treatment Choice. | during visits 1 and 2, up to approximately 3 weeks | Systemic treatment choices are defined as : 1. Chemotherapy (chemo) 2. Immunotherapy (IO) 3. immuno combined therapies (IO+IO) 4. IO+chemo 5. IO+bevacizumab+chemo (IO+bev+chemo) 6. best supportive care (BSC). There is no exposure in this study. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Study Group A total of 215 patients were enrolled in the study and 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria).
All analyses were performed on the Eligible Population.
* Demography data
* Age (years)
* Gender (male or female)
* Weight loss (%)
* Smoking status (current, former (defined as smoking ≥ 1 year), never, or unknown)
* ECOG status (0, 1, 2, 3-4, or unknown)
* Patient's preference for treatment choice (yes, no, or unknown) | 209 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Primary Study Group | — |
|---|---|---|
| Age, Continuous | 68.2 Years STANDARD_DEVIATION 9.2 | — |
| ECOG ECOG 0 | 40 Participants | — |
| ECOG ECOG 1 | 121 Participants | — |
| ECOG ECOG 2 | 34 Participants | — |
| ECOG ECOG 3-4 | 11 Participants | — |
| ECOG Unknown | 3 Participants | — |
| Histology Non-squamous | 137 Participants | — |
| Histology Not otherwise specified | 15 Participants | — |
| Histology Squamous | 57 Participants | — |
| IHC PD-L1 Tumor Proportion Score (TPS) <1% | 69 Participants | — |
| IHC PD-L1 Tumor Proportion Score (TPS) 1-49% | 45 Participants | — |
| IHC PD-L1 Tumor Proportion Score (TPS) >=50% | 88 Participants | — |
| IHC PD-L1 Unknown | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 136 Participants | — |
| Smoking Status Current | 99 Participants | — |
| Smoking Status Former (>1 year) | 101 Participants | — |
| Smoking Status Never | 8 Participants | — |
| Smoking Status Unknown | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 215 |
| other Total, other adverse events | 1 / 215 |
| serious Total, serious adverse events | 13 / 215 |
Outcome results
Primary
The Study Outcome is Defined as the Systemic Treatment Choice.
Systemic treatment choices are defined as : 1. Chemotherapy (chemo) 2. Immunotherapy (IO) 3. immuno combined therapies (IO+IO) 4. IO+chemo 5. IO+bevacizumab+chemo (IO+bev+chemo) 6. best supportive care (BSC). There is no exposure in this study.
Time frame: during visits 1 and 2, up to approximately 3 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Chemotherpay | 26 Participants |
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Immunotherapy | 68 Participants |
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Immunotherapy combined therapies | 0 Participants |
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Immunotherapy + chemotherapy | 99 Participants |
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Immunotherapy + bevacizumab + chemotherapy | 0 Participants |
| Primary Study Group | The Study Outcome is Defined as the Systemic Treatment Choice. | Best supportive care | 16 Participants |