An observational study in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 21 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-28.
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 34th largest by enrollment of the 37 observational ones that give a count, is one of 19 that started in 2011, is one of 37 observational ones, and was the 76th 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: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 19 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is below 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.
This tab as a report to print or save as PDF → With an account.
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:
This tab as a report to print or save as PDF → With an account.
This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Drug: Erlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Also known as: Tarceva
Progression-free Survival
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Baseline to the end of the study (up to 2 years)
Best Overall Response
Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time frame: Baseline to the end of the study (up to 2 years)
Overall Survival
Overall survival was defined as the time from Baseline until death from any cause.
Time frame: Up to 2 years
Percentage of Participants Who Developed Rash
Time frame: Up to 2 years
Percentage of Participants Who Developed Diarrhea
Time frame: Up to 2 years
Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.
| Milestone | Erlotinib |
|---|---|
| Started | 57 |
| Completed | 0 |
| Not completed | 57 |
| Withdrew: Death | 42 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Study termination | 9 |
| Withdrew: Protocol violation | 3 |
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
| Months | Erlotinib |
|---|---|
| Progression-free Survival | 1.8 (1.4 to 2.6) |
Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
| Percentage of participants | Erlotinib |
|---|---|
| Complete Response | 0.0 (0.0 to 6.8) |
| Partial Response | 0.0 (0.0 to 6.8) |
| Stable Disease | 34.6 (21.9 to 49.0) |
| Progressive Disease | 65.4 (50.9 to 78.0) |
Overall survival was defined as the time from Baseline until death from any cause.
| months | Erlotinib |
|---|---|
| Overall Survival | 5.8 (3.3 to 8.6) |
| percentage of participants | Erlotinib |
|---|---|
| Percentage of Participants Who Developed Rash | 60.7 (46.7 to 73.5) |
| percentage of participants | Erlotinib |
|---|---|
| Percentage of Participants Who Developed Diarrhea | 42.8 (29.7 to 56.8) |
Collected over Time frame is up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib | — | 17/57 (29.8%) | 51/57 (89.5%) |
| Event | Erlotinib |
|---|---|
| General physical health deteriorationGeneral disorders | 3/57 |
| PyrexiaGeneral disorders | 2/57 |
| PneumoniaInfections and infestations | 2/57 |
| AnaemiaBlood and lymphatic system disorders | 1/57 |
| Sinus tachycardiaCardiac disorders | 1/57 |
| Abdominal painGastrointestinal disorders | 1/57 |
| NauseaGastrointestinal disorders | 1/57 |
| VomitingGastrointestinal disorders | 1/57 |
| InfectionInfections and infestations | 1/57 |
| C-reactive protein increaseInvestigations | 1/57 |
| Event | Erlotinib |
|---|---|
| RashSkin and subcutaneous tissue disorders | 35/57 |
| DiarrheaGastrointestinal disorders | 25/57 |
| Decreased appetiteMetabolism and nutrition disorders | 13/57 |
| Weight decreasedInvestigations | 8/57 |
| AstheniaGeneral disorders | 6/57 |
| NauseaGastrointestinal disorders | 5/57 |
| PyrexiaGeneral disorders | 5/57 |
| AnaemiaBlood and lymphatic system disorders | 5/57 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/57 |
| VomitingGastrointestinal disorders | 4/57 |
Baseline analysis population is represented as the per protocol population.
| Age, Continuous(Years) | Erlotinib |
|---|---|
| Mean | 64.4 ± 8.9 |
| Sex: Female, Male(Participants) | Erlotinib |
|---|---|
| Female | 18 |
| Male | 36 |
The record gives a start of Sep 2011, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2015, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →