An observational study in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 37 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Hoffmann-La Roche · Observational
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Among 182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche — 5 open to participants now, 16 under way, 8 of them phase 3. Carcinoma, Non-Small-Cell Lung · Hoffmann-La Roche.
Among the 182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche, this one is the 16th largest by enrollment of the 37 observational ones that give a count, is one of 13 that started in 2017, is one of 37 observational ones, and was the 133rd registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →5 of the 182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States, Argentina, Belgium and 16 more countries
Ages 18+
Chugai Pharmaceutical · Sites in United States, Japan
Ages 18+
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 25 more countries
Ages 18+
Hoffmann-La Roche · Sites in China
Ages 18+
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 15 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
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182 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 66 · Phase 3 50 · Phase 4 10
First in 2001; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 355 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 136 across the 142 interventional studies, 289 across the 37 observational. Of the 161 that completed or were terminated, 96 (60%) have results posted.
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Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
5 of the studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05170204Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) | 2027-01-19 |
| NCT03178552Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) | 2027-06-30 |
| NCT04302025Genentech, Inc.A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) | 2026-11-30 |
| NCT04140500Hoffmann-La RocheDose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors | 2027-06-30 |
| NCT02568267Hoffmann-La RocheBasket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) | 2027-06-30 |
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Among the 182 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche, from their registry updates:
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Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.
Participants with ALK-positive, locally advance or metastatic non-small cell lung cancer, who are administered alectinib at physician's discretion in Korea.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.
Drug: Alectinib
According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).
Also known as: Alecensa
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to approximately 3 years
Overall Response Rate (ORR)
ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis \<10 millimeter (mm); PR is defined as \>/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR.
Time frame: Up to approximately 3 years
Complete Response (CR)
CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis \<10 mm. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Time frame: Up to approximately 3 years
Percentage of Participants with Partial Response (PR)
PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as \>/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Time frame: Up to approximately 3 years
Percentage of Participants with Stable Disease (SD)
SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least \>/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as \>/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and \>/= 5 mm in absolute value. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Time frame: Up to approximately 3 years
Percentage of Participants with Progressive Disease (PD)
PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as \>/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and \>/= 5 mm in absolute value. Target lesions are those lesions with longest diameter \>/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures \>/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
Time frame: Up to approximately 3 years
Ran from Nov 2017 to primary completion in May 2021, 42 months.
Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's 42 months is below that.
Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →