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Descriptive Observational Study ALK-2016-CPHG
trial in NSCLC in 73 participants. Completed in 1 July 2020.
| Lead sponsor | Pfizer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 73 |
| Start date | 3 January 2017 |
| Primary completion | 1 July 2020 |
| Estimated completion | 1 July 2020 |
| Sites | 26 locations across France |
Pfizer — full company profile →
18 and older, any sex, with NSCLC or Crizotinib. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 62.3 | ± 15.1 |
| Crizotinib: Second Line of Treatment | 63.1 | ± 12.9 |
| Crizotinib: Third Line of Treatment | 56.5 | ± 3.5 |
| Crizotinib: Other Line of Treatment | 64.3 | ± 3.2 |
Body weight in kilograms (kg) measured at baseline were reported.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 66.5 | ± 15.5 |
| Crizotinib: Second Line of Treatment | 69.3 | ± 13.8 |
| Crizotinib: Third Line of Treatment | 75.0 | ± 0.0 |
| Crizotinib: Other Line of Treatment | 58.5 | ± 14.8 |
| Participants With ALK Gene Rearrangement | 69.6 | ± 14.6 |
| Participants With ROS1 Gene Rearrangement | 61.1 | ± 14.1 |
BMI was obtained by dividing body weight in kilograms (kg) by height in meters square (m\^2).
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 24.34 | ± 4.46 |
| Crizotinib: Second Line of Treatment | 24.73 | ± 4.84 |
| Crizotinib: Third Line of Treatment | 25.05 | ± 0.78 |
| Crizotinib: Other Line of Treatment | 23.50 | ± 4.95 |
| Participants With ALK Gene Rearrangement | 25.07 | ± 4.59 |
| Participants With ROS1 Gene Rearrangement | 22.81 | ± 3.57 |
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 17 | |
| Crizotinib: Second Line of Treatment | 7 | |
| Crizotinib: Third Line of Treatment | 2 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Crizotinib: First Line of Treatment | 34 | |
| Crizotinib: Second Line of Treatment | 8 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 3 |
Number of participants were classified according to smoking status as non-smoker, ex-smoker (did not smoke in at least 1 year prior to baseline) and current-smoker.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 31 | |
| Crizotinib: Second Line of Treatment | 7 | |
| Crizotinib: Third Line of Treatment | 1 | |
| Crizotinib: Other Line of Treatment | 1 | |
| Participants With ALK Gene Rearrangement | 28 | |
| Participants With ROS1 Gene Rearrangement | 12 | |
| Crizotinib: First Line of Treatment | 19 | |
| Crizotinib: Second Line of Treatment | 5 | |
| Crizotinib: Third Line of Treatment | 1 | |
| Crizotinib: Other Line of Treatment | 2 | |
| Participants With ALK Gene Rearrangement | 19 | |
| Participants With ROS1 Gene Rearrangement | 8 | |
| Crizotinib: First Line of Treatment | 1 | |
| Crizotinib: Second Line of Treatment | 3 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 4 | |
| Participants With ROS1 Gene Rearrangement | 0 |
The number of pack-years was calculated at baseline for ex-smokers and current smokers by multiplying the number of packs they consumed per day and the number of years that the participant had smoked this quantity of packs. Combined data is reported for ex-smokers and current smokers.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 19.7 | ± 17.2 |
| Crizotinib: Second Line of Treatment | 24.5 | ± 9.7 |
| Crizotinib: Third Line of Treatment | 60.0 | |
| Crizotinib: Other Line of Treatment | 10.0 | ± 0.0 |
| Participants With ALK Gene Rearrangement | 21.7 | ± 16.1 |
| Participants With ROS1 Gene Rearrangement | 20.5 | ± 19.9 |
Duration of smoking: a) for ex-smokers, duration of smoking (years) was calculated by subtracting start year with year of smoking stop, b) for current smokers, duration of smoking (years) was calculated by subtracting start year with year of Inclusion visit date. Combined data of duration of smoking is reported for ex-smokers and current smokers. Duration of quitting smoke (years) for ex-smokers was calculated by subtracting year of smoking stop with year of inclusion visit date.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 22.6 | ± 13.6 |
| Crizotinib: Second Line of Treatment | 26.0 | ± 13.5 |
| Crizotinib: Third Line of Treatment | 36.0 | |
| Participants With ALK Gene Rearrangement | 23.1 | ± 12.8 |
| Participants With ROS1 Gene Rearrangement | 25.9 | ± 14.9 |
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 12.8 | ± 14.3 |
| Crizotinib: Second Line of Treatment | 12.6 | ± 15.4 |
| Crizotinib: Third Line of Treatment | 3.0 | |
| Crizotinib: Other Line of Treatment | 8.0 | ± 2.8 |
| Participants With ALK Gene Rearrangement | 10.5 | ± 14.4 |
| Participants With ROS1 Gene Rearrangement | 15.1 | ± 11.6 |
Number of participants were categorized as yes or no, according to have undergone assessment with ECOG performance status. ECOG performance status was used to measure quality of life of oncology participants with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>) 50 percent (%) of waking hours; 3
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 5 | |
| Crizotinib: Second Line of Treatment | 2 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 1 | |
| Participants With ALK Gene Rearrangement | 7 | |
| Participants With ROS1 Gene Rearrangement | 1 | |
| Crizotinib: First Line of Treatment | 46 | |
| Crizotinib: Second Line of Treatment | 13 | |
| Crizotinib: Third Line of Treatment | 2 | |
| Crizotinib: Other Line of Treatment | 2 | |
| Participants With ALK Gene Rearrangement | 44 | |
| Participants With ROS1 Gene Rearrangement | 19 |
ECOG performance status was used to measure quality of life of oncology patients with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50% of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confin
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 36 | |
| Crizotinib: Second Line of Treatment | 12 | |
| Crizotinib: Third Line of Treatment | 2 | |
| Crizotinib: Other Line of Treatment | 2 | |
| Participants With ALK Gene Rearrangement | 38 | |
| Participants With ROS1 Gene Rearrangement | 14 | |
| Crizotinib: First Line of Treatment | 10 | |
| Crizotinib: Second Line of Treatment | 1 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 6 | |
| Participants With ROS1 Gene Rearrangement | 5 |
Time since diagnosis of NSCLC (months) was calculated as: inclusion visit date minus date of the biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 1.30 | 0.70 – 2.30 |
| Crizotinib: Second Line of Treatment | 8.00 | 3.40 – 39.70 |
| Crizotinib: Third Line of Treatment | 48.40 | 33.60 – 63.20 |
| Crizotinib: Other Line of Treatment | 61.70 | 11.70 – 135.90 |
| Participants With ALK Gene Rearrangement | 2.70 | 1.00 – 6.00 |
| Participants With ROS1 Gene Rearrangement | 1.25 | 0.80 – 1.90 |
Participants were categorized according to type of tumor's histology as adenocarcinoma, carcinoma indifferencier and other.
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 50 | |
| Crizotinib: Second Line of Treatment | 15 | |
| Crizotinib: Third Line of Treatment | 2 | |
| Crizotinib: Other Line of Treatment | 3 | |
| Participants With ALK Gene Rearrangement | 51 | |
| Participants With ROS1 Gene Rearrangement | 19 | |
| Crizotinib: First Line of Treatment | 1 | |
| Crizotinib: Second Line of Treatment | 0 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 0 | |
| Participants With ROS1 Gene Rearrangement | 0 | |
| Crizotinib: First Line of Treatment | 0 | |
| Crizotinib: Second Line of Treatment | 0 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 0 | |
| Participants With ROS1 Gene Rearrangement | 1 |
Participants were categorized according to tumor stage as IIIA/B or IVA/B classified as per Tumor Node Metastasis (TNM), 8th edition. TNM: based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. Stages included: stage 0 (no evidence of cancer cells), stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIb (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), where T0= early form of tumor, T1=\<2 centimeter (cm), T2 =2-5 cm
| Group | Value | 95% CI |
|---|---|---|
| Crizotinib: First Line of Treatment | 0 | |
| Crizotinib: Second Line of Treatment | 4 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 4 | |
| Participants With ROS1 Gene Rearrangement | 0 | |
| Crizotinib: First Line of Treatment | 5 | |
| Crizotinib: Second Line of Treatment | 0 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 0 | |
| Participants With ALK Gene Rearrangement | 3 | |
| Participants With ROS1 Gene Rearrangement | 2 | |
| Crizotinib: First Line of Treatment | 18 | |
| Crizotinib: Second Line of Treatment | 5 | |
| Crizotinib: Third Line of Treatment | 2 | |
| Crizotinib: Other Line of Treatment | 1 | |
| Participants With ALK Gene Rearrangement | 20 | |
| Participants With ROS1 Gene Rearrangement | 6 | |
| Crizotinib: First Line of Treatment | 28 | |
| Crizotinib: Second Line of Treatment | 6 | |
| Crizotinib: Third Line of Treatment | 0 | |
| Crizotinib: Other Line of Treatment | 2 | |
| Participants With ALK Gene Rearrangement | 24 | |
| Participants With ROS1 Gene Rearrangement | 12 |
Time frame: Up to maximum of 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Crizotinib: First Line of … | Crizotinib: Second Line of… | Crizotinib: Third Line of … | Crizotinib: Other Line of … | Participants With ALK Gene… | Participants With ROS1 Gen… | Participants With Unknown … |
|---|---|---|---|---|---|---|---|---|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | — | — | — | — | — | — | — |
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — | — |
| DEATH | General disorders | — | — | — | — | — | — | — |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| ASTHENIA | General disorders | — | — | — | — | — | — | — |
| CHEST PAIN | General disorders | — | — | — | — | — | — | — |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — | — | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — | — | — | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — | — | — | — |
| BRONCHITIS | Infections and infestations | — | — | — | — | — | — | — |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | — | — | — | — | — | — | — |
| VERTIGO | Ear and labyrinth disorders | — | — | — | — | — | — | — |
| COMPLICATION ASSOCIATED WITH DEVICE | General disorders | — | — | — | — | — | — | — |
| CONDITION AGGRAVATED | General disorders | — | — | — | — | — | — | — |
| PYREXIA | General disorders | — | — | — | — | — | — | — |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — | — | — | — | — |
| INTESTINAL INFARCTION | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Reaction | System | Crizotinib: First Line of … | Crizotinib: Second Line of… | Crizotinib: Third Line of … | Crizotinib: Other Line of … | Participants With ALK Gene… | Participants With ROS1 Gen… | Participants With Unknown … |
|---|---|---|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — | — | — | — | — |
| VISUAL IMPAIRMENT | Eye disorders | — | — | — | — | — | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — | — | — | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — | — | — | — | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — | — | — | — | — |
| ASTHENIA | General disorders | — | — | — | — | — | — | — |
| PARAESTHESIA | Nervous system disorders | — | — | — | — | — | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — | — | — | — | — | — |
| FATIGUE | General disorders | — | — | — | — | — | — | — |
| DYSGEUSIA | Nervous system disorders | — | — | — | — | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — | — | — | — | — | — | — |
| WEIGHT DECREASED | Investigations | — | — | — | — | — | — | — |
| WEIGHT INCREASED | Investigations | — | — | — | — | — | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| RENAL FAILURE | Renal and urinary disorders | — | — | — | — | — | — | — |
| VERTIGO | Ear and labyrinth disorders | — | — | — | — | — | — | — |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | — | — | — | — | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — | — | — | — | — |
| VISION BLURRED | Eye disorders | — | — | — | — | — | — | — |
| PHOTOPSIA | Eye disorders | — | — | — | — | — | — | — |
| VISUAL ACUITY REDUCED | Eye disorders | — | — | — | — | — | — | — |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | — | — | — | — | — | — | — |
| TRANSAMINASES INCREASED | Investigations | — | — | — | — | — | — | — |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| DYSPHAGIA | Gastrointestinal disorders | — | — | — | — | — | — | — |
| CHEST PAIN | General disorders | — | — | — | — | — | — | — |
| CREPITATIONS | General disorders | — | — | — | — | — | — | — |
| FACE OEDEMA | General disorders | — | — | — | — | — | — | — |
| TASTE DISORDER | Nervous system disorders | — | — | — | — | — | — | — |
| DIZZINESS | Nervous system disorders | — | — | — | — | — | — | — |
| TREMOR | Nervous system disorders | — | — | — | — | — | — | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — | — | — | — | — | — | — |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | — | — | — | — | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
Most-reported serious reactions: GENERAL PHYSICAL HEALTH DETERIORATION, NEOPLASM PROGRESSION, DEATH, PLEURAL EFFUSION, SPINAL PAIN, ASTHENIA, CHEST PAIN, LUNG DISORDER.
Data from ClinicalTrials.gov NCT03718117 adverse events section.
Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
1 peer-reviewed publication reference this trial (live from Europe PMC):
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