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Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer Stage IV

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Trial Information

Randomized Phase 2 Study of Gemcitabine/Cisplatin With or Without SAR240550 (BSI-201), a PARP1 Inhibitor, in Patients With Stage IV Non-small Cell Lung Cancer

The duration of the study for a patient will include a period for inclusion of up to 3
weeks. The patients may continue treatment up to a maximum of 6 cycles or until disease
progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day
follow-up after the last study treatment administration.

Patients will be followed for at least 30 days after the last administration of study
treatment for safety purpose. In case of study treatment discontinuation without disease
progression, efficacy data will be collected every 6 weeks until disease progression, death
or end of study whatever comes first. After disease progression, the patient will be
followed-up every 12 weeks (3 months) for overall survival (OS) until death or end of study
whatever comes first.

The end of the study will be one year after the first dose of the last treated patient.

Inclusion Criteria

Inclusion criteria:

- Stage IV disease (including stage IIIB with pleural effusion) with no prior systemic
therapy. Adjuvant therapy is allowed if ended more than 1 year before inclusion in
the study.

- Histologically confirmed squamous cell bronchogenic carcinoma OR non squamous cell

- Patients with previous radiotherapy as definitive therapy for locally advanced
non-small cell lung cancer are eligible, as long as the selected measurable lesions
are outside the original radiation therapy port. Radiation therapy must have been
completed >4 weeks prior to study entry.

- Palliative radiotherapy must have been completed > 2 weeks prior to study entry.
Irradiated lesions may not serve as measurable lesions.

- At least one measurable lesion according to the Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Adequate bone marrow reserve.

- Adequate liver and renal function.

- Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment.

Exclusion criteria:

- Prior treatment with gemcitabine, platinum salts or any PARP inhibitor class

- Past or current history of neoplasm other than the entry diagnosis, with the
exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or
other cancers cured by local therapy alone and with an expected disease-free survival
of > or = 5 years.

- Major medical conditions that might affect study participation e.g. cardiac disease,
uncontrolled infection (>Grade 2).

- Presence of active brain metastases.

- A major surgical procedure, open biopsy, or significant traumatic injury within 28
days of beginning treatment, or anticipation of the need for major surgery during the
course of the study.

- Any history of medical or psychiatric condition or laboratory abnormality that, in
the opinion of the investigator, may increase the risks associated with the study
participation or administration of the investigational products, or that may
interfere with the interpretation of the results

- Grade 2 or higher ear and labyrinth disorders.

- Known or suspected allergy/hypersensitivity to any agent given in the course of this

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate (ORR) that is defined in the RECIST 1.1 version, as: complete response rate + partial response rate

Outcome Time Frame:

up to a maximum follow-up of 25 weeks

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



Italy: Ethics Committee

Study ID:




Start Date:

May 2010

Completion Date:

December 2011

Related Keywords:

  • Non-small Cell Lung Cancer Stage IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms