N/A
N=73
Descriptive Observational Study ALK-2016-CPHG
NSCLC · Crizotinib · ALK Gene Rearrangement or ROS1 Gene Rearrangement
Bottom Line
View on ClinicalTrials.gov: NCT03718117 ↗Enrolled (actual)
73
Serious AEs
54.2%
Results posted
Sep 2024
Primary outcome: Primary: Age: Line of Treatment — 62.3; 63.1; 56.5; 64.3 Years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age: Line of Treatment |
62.3; 63.1; 56.5; 64.3 | — |
| PRIMARY Body Weight: Line of Treatment and Gene Rearrangement |
66.5; 69.3; 75.0; 58.5; 69.6; 61.1 | — |
| PRIMARY Body Mass Index (BMI): Line of Treatment and Gene Rearrangement |
24.34; 24.73; 25.05; 23.50; 25.07; 22.81 | — |
| PRIMARY Gender: Line of Treatment |
17; 7; 2; 0; 34; 8 | — |
| PRIMARY Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement |
31; 7; 1; 1; 28; 12 | — |
| PRIMARY Number of Pack Years: Line of Treatment and Gene Rearrangement |
19.7; 24.5; 60.0; 10.0; 21.7; 20.5 | — |
| PRIMARY Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement |
22.6; 26.0; 36.0; 23.1; 25.9; 12.8 | — |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement |
5; 2; 0; 1; 7; 1 | — |
| PRIMARY Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement |
36; 12; 2; 2; 38; 14 | — |
| PRIMARY Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement |
1.30; 8.00; 48.40; 61.70; 2.70; 1.25 | — |
| PRIMARY Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement |
50; 15; 2; 3; 51; 19 | — |
| PRIMARY Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement |
0; 4; 0; 0; 4; 0 | — |
| PRIMARY Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement |
15; 2; 1; 1; 11; 8 | — |
| PRIMARY Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement |
6; 2; 0; 0; 6; 2 | — |
| PRIMARY Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement |
20; 5; 1; 2; 19; 9 | — |
| PRIMARY Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement |
17; 4; 1; 1; 18; 5 | — |
| PRIMARY Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement |
1.00; 6.90; 44.45; 60.10; 6.90; 65.95 | — |
| PRIMARY Number of Participants Categorized as "Yes" or "No" for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement |
9; 0; 0; 0; 4; 5 | — |
| PRIMARY Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement |
4.0; 5.0; 4.0; 4.0; 13.5; 3.0 | — |
| PRIMARY Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement |
2.70; 3.60; 2.60; 2.65; 11.30; 1.85 | — |
| PRIMARY Number of Participants Categorized as "Yes" or "No" for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement |
6; 0; 0; 0; 2; 4 | — |
| PRIMARY Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement |
30.0; 30.0; 20.0; 42.5; 30.0; 30.0 | — |
| PRIMARY Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement |
15.0; 15.0; 7.0; 30.5; 15.0; 15.0 | — |
| SECONDARY Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement |
47; 13; 2; 2; 44; 20 | — |
| SECONDARY Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement |
37; 10; 2; 3; 36; 16 | — |
| SECONDARY Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement |
10; 1; 0; 0; 4; 7 | — |
| SECONDARY Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement |
46; 14; 2; 2; 47; 17 | — |
| SECONDARY Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement |
8.0; 18.0; 19.5; 11.0; 10.0; 8.0 | — |
| SECONDARY Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement |
2; 4; 0; 0; 4; 2 | — |
| SECONDARY Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18 |
4; 0; 0; 0; 1; 3 | — |
| SECONDARY Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18 |
4.30; 35.45; 35.90; 6.70; 2.90; 7.10 | — |
| SECONDARY Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18 |
1; 0; 1; 1; 1; 2 | — |
| SECONDARY Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 |
4; 2; 1; 6; 1; 6 | — |
| SECONDARY Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18 |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 |
3; 1; 0; 3; 1; 3 | — |
| SECONDARY Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18 |
2; 1; 3; 0; 1; 0 | — |
| SECONDARY Treatment Duration Until Progression With Brain Metastases |
35.55; 29.70; 29.40; 62.00 | — |
| SECONDARY Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18 |
4; 1; 0; 4; 1; 1 | — |
| SECONDARY Objective Response Rate (ORR) |
56.9; 66.7; 50; 100; 62.7; 55 | — |
| SECONDARY Disease Control Rate (DCR) at Month 12 and 18 |
76.5; 80; 50; 100; 78.4; 75 | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18 |
33.30; 33.30; 16.65; 50.00; 33.30; 33.30 | — |
| SECONDARY Time to Median Progression Free Survival (Months) With Its 95%CI |
9.2; 9.2; NA; NA; 9.4; 6.6 | — |
| SECONDARY 18-Month Overall Survival (OS) Rate (95%CI) |
61.5; 77.8; NA; NA; 77.5; 40.5 | — |
| SECONDARY Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18 |
13; 2; 1; 1; 11; 6 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
49; 13; 2; 3; 47; 20 | — |
Summary
Descriptive Observational Study.
Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
Eligibility Criteria
Inclusion criteria
- Age ≥ 18 years
- Locally advanced or metastatic NSCLC
- Patient ALK gene rearrangement or ROS1 gene rearrangement
- Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
- Patient followed up by a physician in a hospital pulmonary medicine department
- Subject of reproductive age, using an effective method of contraception
- Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.
Non-inclusion criteria
- Patient included within the scope of an interventional therapeutic trial
- Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
- Patient not available for follow-up throughout the duration of the study
- Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.
Data sourced from ClinicalTrials.gov (NCT03718117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.