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Standard platinum-based chemotherapy

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 11, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

Standard platinum-based chemotherapy · 1 trial · 1 indication

Phase 2 1
NCT00531960A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.Non-Small Cell Lung Cancer
COMPLETED124 Analytics
PHASE2COMPLETED
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Disease Progression or Death
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.

PFS
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.

Secondary Endpoints

Percentage of Participants Who Died
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
OS
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bevacizumab, ChemotherapyACTIVE_COMPARATORParticipants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m\^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m\^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m\^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (\*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
Bevacizumab, ErlotinibEXPERIMENTALParticipants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.

Interventions

NameTypeDescription
ErlotinibDRUG150 mg, PO, daily
BevacizumabDRUG15 mg/kg, IV, Day 1 of Cycles 1 through 7
Standard platinum-based chemotherapyDRUGAt the discretion of the investigator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * adult patients, \>=18 years of age; * advanced (stage IIIb and IV) non-small cell lung cancer; * measurable disease; * ECOG PS 0-1. Exclusion Criteria: * prior chemotherapy or treatment with another systemic anti-cancer agent; * radiotherapy within 4 weeks prior to first dos...

Countries:AustraliaBelgiumFranceItalyLithuaniaNetherlandsPolandRomaniaSingaporeSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about Standard platinum-based chemotherapy

What is Standard platinum-based chemotherapy used for?

Standard platinum-based chemotherapy is used for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is a small molecule oncology therapy that was studied in a Phase 2 clinical trial in combination with other agents for patients with advanced disease.

Who makes Standard platinum-based chemotherapy?

Standard platinum-based chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 2 clinical trial evaluating this treatment regimen in patients with Non-Small Cell Lung Cancer.

What phase is Standard platinum-based chemotherapy in?

Standard platinum-based chemotherapy is in Phase 2 clinical development. It is an investigational treatment for Non-Small Cell Lung Cancer and has completed one Phase 2 trial, but it is not yet approved by regulatory authorities.

What clinical trials is Standard platinum-based chemotherapy in?

Standard platinum-based chemotherapy was studied in one completed Phase 2 clinical trial, NCT00531960. This trial enrolled 124 patients with advanced Non-Small Cell Lung Cancer and was conducted across multiple countries including Australia, Belgium, France, Italy, and the United Kingdom.

Is Standard platinum-based chemotherapy the same as Tarceva or Avastin?

No, Standard platinum-based chemotherapy is not the same as Tarceva (erlotinib) or Avastin (bevacizumab). These are separate drugs that were studied in combination with Standard platinum-based chemotherapy in the clinical trial NCT00531960 for Non-Small Cell Lung Cancer.