A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
CompletedPhase 2Results postedLast updated 17 September 2018
What this trial tests
Phase 2 trial testing erlotinib [Tarceva] in Non-Squamous Non-Small Cell Lung Cancer in 60 participants. Completed in 20 December 2016.
18 and older, any sex, with Non-Squamous Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) According to Grade of RashPrimary· Day 1 of treatment period until disease progression or death (approximately up to 67 months)
PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Grade 0
Group
Value
95% CI
Erlotinib
2.16
1.51 – NA
Grade 1
Group
Value
95% CI
Erlotinib
6.62
3.57 – 13.48
Grade 2
Group
Value
95% CI
Erlotinib
10.00
7.31 – 23.61
Grade 3
Group
Value
95% CI
Erlotinib
15.28
10.62 – 25.77
Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4Secondary· Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Rash Grade III
Group
Value
95% CI
Erlotinib
8.5
Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4Secondary· Day 1 of treatment period until disease progression or death (approximately up to 67 months)
PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Rash grade III
Group
Value
95% CI
Erlotinib
13.72
7.31 – 50.13
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing of informed consent form up to end of study (approximately up to 67 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Erlotinib
Serious: 19/59 (32%)
Deaths: 4/59
Serious adverse events (34 terms)
Reaction
System
Erlotinib
Acute kidney injury
Renal and urinary disorders
—
Bradycardia
Cardiac disorders
—
Vision blurred
Eye disorders
—
Diarrhea
Gastrointestinal disorders
—
Duodenal ulcer
Gastrointestinal disorders
—
Gastritis
Gastrointestinal disorders
—
Gastroduodenitis
Gastrointestinal disorders
—
Hematemesis
Gastrointestinal disorders
—
Chest pain
General disorders
—
General physical health deterioration
General disorders
—
Pyrexia
General disorders
—
Ophthalmic herpes zoster
Infections and infestations
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Upper respiratory tract infection
Infections and infestations
—
Fall
Injury, poisoning and procedural complications
—
Femoral neck fracture
Injury, poisoning and procedural complications
—
Fractured sacrum
Injury, poisoning and procedural complications
—
Hip fracture
Injury, poisoning and procedural complications
—
Upper limb fracture
Injury, poisoning and procedural complications
—
Hypocalcaemia
Metabolism and nutrition disorders
—
Hypokalemia
Metabolism and nutrition disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 17 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01174563.