Preclinical and clinical evaluation of the activity of Docetaxel and Gemcitabine in chemonaive ERCC1-positive locally advanced or metastatic Non-Small Cell Lung Cancer patients (PLP-09) - PLP-09

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010656-10-IT

Enrollment

Registered

2009-03-09

Start date

2009-03-09

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemonaive ERCC1-positive locally advanced or metastatic Non-Small Cell Lung Cancer patients MedDRA version: 9.1 Level: SOC Classification code 10038738

Interventions

Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Gemcitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Pharmaceutical Form: Solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically/cytologically confirmed diagnosis of stage IIIB/IV NSCLC - ERCC1 positive NSCLC (IHC and RT-PCR whenever possible) - No prior chemotherapy for advanced disease - At least 1 measurable (target) lesion according to RECIST criteria. - Age > 18 3months - Neutrophils>1.5x10e9/L, Platelets >100x10e9/L, Hb>9 g/dl, AST e ALT =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Prior chemotehrapy or radiotherapy for advanced disease - Adjuvant therapy with gemcitabina and or docetaxel if administered in the last year - Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investiagator would place the subject at undue risk or interfere with the results of the study - Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years - Symptomatic brain metastasis or leptomeningeal disease requiring therapy - Pregnancy or lactation or unwillingness to use adeguate method of birth control

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Pre-clinical identification of the best sequential combination of Docetaxel and Gemcitabine in NSCLC cell lines characterized for ERCC1 expression. 2. Clinical evaluation of antitumor activity (response rate, RECIST) of the combination of Docetaxel and Gemcitabine in chemonaive ERCC1 pos stage IIIB/IV NSCLC;Secondary Objective: 1. To define the safety profile of the combination of Docetaxel and Gemcitabine 2. To define the time to progression (TTP) and overall survival (OS) of the patients 3. To evaluate the concordance between the RT-PCR and IHC determination of ERRC1 4. Quality of life evaluation with questionnaire QLQ-C30;Primary end point(s): Clinical evaluation of antitumor activity (response rate, RECIST) of the combination of Docetaxel and Gemcitabine in chemonaive ERCC1 pos stage IIIB/IV NSCLC	—

Measure

Time frame

Main Objective: 1. Pre-clinical identification of the best sequential combination of Docetaxel and Gemcitabine in NSCLC cell lines characterized for ERCC1 expression. 2. Clinical evaluation of antitumor activity (response rate, RECIST) of the combination of Docetaxel and Gemcitabine in chemonaive ERCC1 pos stage IIIB/IV NSCLC;Secondary Objective: 1. To define the safety profile of the combination of Docetaxel and Gemcitabine 2. To define the time to progression (TTP) and overall survival (OS) of the patients 3. To evaluate the concordance between the RT-PCR and IHC determination of ERRC1 4. Quality of life evaluation with questionnaire QLQ-C30;Primary end point(s): Clinical evaluation of antitumor activity (response rate, RECIST) of the combination of Docetaxel and Gemcitabine in chemonaive ERCC1 pos stage IIIB/IV NSCLC

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026