AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer

NCT02513563 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCC-18304
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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).

  Up to 2 years

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 2 years

• Duration of Overall Response (OR)

  Up to 2 years

• Percentage of Participants With Disease Control

  Up to 2 years

Study Arms (1)

Carboplatin/Paclitaxel/AZD1775

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Paclitaxel; Drug: AZD1775

Interventions

Carboplatin DRUG

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.

Also known as: Paraplatin®

Carboplatin/Paclitaxel/AZD1775

Paclitaxel DRUG

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.

Also known as: TAXOL®

Carboplatin/Paclitaxel/AZD1775

AZD1775 DRUG

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.

Also known as: MK1775

Carboplatin/Paclitaxel/AZD1775

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Histologic or cytological diagnosis of Squamous Cell Lung Cancer (SQCLC) with advanced/metastatic stage, with no known curative treatment options. Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first line therapy only if recurrent (local or metastatic) disease developed within 6 months of completing therapy. Potential participants with recurrent disease \> 6 months will be eligible.
• Female or male aged \>/= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
• Prior chemotherapy in the adjuvant setting is allowed
• Prior radiotherapy is allowed
• Any prior palliative radiation must have been completed at least 7 days prior to the start of the studies drugs and participants must have been recovered from any acute adverse effects prior to the start of the study treatment
• Prior Immunotherapy with PD1i, PDL1i, anti-CTLA -4 or vaccines is allowed
• Must have normal organ and marrow function
• Have archival tissue available or undergo a fresh biopsy where clinically feasible after discussion with the sponsor
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation and women who are breast feeding are excluded from the study. Both women and men should be fully informed of the lack of reproductive toxicity testing, and women must have a negative pregnancy test prior to enrollment.

You may not qualify if:

• Progressive, symptomatic untreated brain metastases
• Pregnancy or breast feeding
• A serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the participant's ability to receive study treatment
• Prior use of platinum or paclitaxel for stage IV Non-small Cell Lung Cancer (NSCLC) or concurrent use of other anticancer approved or investigational agents
• Use of anti-cancer treatment drug ?21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775. For drugs for which 5 half-lives is \<21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required.
• Major surgical procedures ?28 days of beginning study treatment, or minor surgical procedures ?7 days. No waiting period required following port-a-cath or other central venous access placement.
• Grade \>1 toxicity from prior therapy EXCEPT: Alopecia, anorexia, and/or endocrinopathies on replacement therapy.
• Unable to swallow oral medications. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
• Known Hepatitis B or C or HIV infection
• Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 2 years previously with no evidence of recurrence
• Any of the following cardiac diseases currently or within the last 6 months: unstable angina pectoris, acute myocardial infarction, congestive heart failure \> Class 2 (as defined by New York Heart Association (NYHA)), conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
• Have had prescription or non-prescription drugs or other products (i.e., grapefruit juice) known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 2 weeks before Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug
• Co-administration of aprepitant and fosaprepitant during this study is prohibited
• AZD1775 is an inhibitor of breast cancer resistance protein (BCRP). The use of statins including Atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives
• Herbal preparations are not allowed throughout the study. These herbal medications include, but are not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Paclitaxel; adavosertib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Jhanelle E. Gray, MD
• Organization: Moffitt Cancer Center

Jhanelle.Gray@moffitt.org

813-745-2677

Study Officials

• Jhanelle Gray, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: July 31, 2015
• Study Start: October 13, 2015
• Primary Completion: November 27, 2022
• Study Completion: November 28, 2023
• Last Updated: February 19, 2026
• Results First Posted: January 10, 2024

Record last verified: 2026-02

Locations

US (2)