Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Adavosertib

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.

Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

AZD1775

Jhanelle Gray, M.D.

The purpose of this study is to find out what effects (good and bad) AZD1775 used in combination with carboplatin and paclitaxel will have on participants and their cancer.

AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

A Phase II Trial of AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death.

The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD).

H. Lee Moffitt Cancer Center and Research Institute

Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.

Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.

Spots Global Cancer Trial Database for AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial