Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial)

2020-02-17 18:20:54 | BioPortfolio


This phase II LUNG-MAP treatment trial studies how well sapanisertib and docetaxel work for the treatment for squamous cell lung cancer that is stage IV or has come back (recurrent). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sapanisertib and docetaxel may work better in treating patients with squamous cell lung cancer compared to standard chemotherapy.



I. To compare the investigator-assessed progression-free survival (IA-PFS) between patients with NFE2L2 or KEAP1-positive stage IV or recurrent squamous cell lung cancer (SQCLC) randomized to TAK228 (MLN0128, sapanisertib) + docetaxel versus standard of care therapy.


I. To compare overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms.

II. To compare overall survival (OS) between the treatment arms. III. To evaluate duration of response (DOR) among responders within each treatment arm.

IV. To evaluate and compare the frequency and severity of toxicities associated within each treatment arm.

V. To evaluate outcomes of IA-PFS, OS, and response in the subsets of patients eligible based on the presence of NFE2L2 versus KEAP1 alterations.


I. To collect, process, and bank cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline, cycle 2 day 1, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA).

II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive docetaxel intravenously (IV) and dexamethasone IV over 30 minutes on days 1 and 8 and sapanisertib orally (PO) once daily (QD) on days 2-4, 9-11, and 16-18. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel is discontinued, patients receive sapanisertib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive standard of care treatment comprising either docetaxel IV and dexamethasone IV over 30 minutes on day 1 or docetaxel IV, dexamethasone IV over 30 minutes, and ramucirumab IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then at 3 years.

Study Design


Lung Squamous Cell Carcinoma


Dexamethasone, Docetaxel, Ramucirumab, Sapanisertib


Not yet recruiting


Southwest Oncology Group

Results (where available)

View Results


Published on BioPortfolio: 2020-02-17T18:20:54-0500

Clinical Trials [7700 Associated Clinical Trials listed on BioPortfolio]

Phase II Trial of Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy

This is a multicenter, randomized, controlled, open-label phase II study including patients with squamous-cell carcinoma of the esophagus, refractory or intolerant to combination therapy w...

Study of Ramucirumab or IMC-18F1 With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line ...

A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC)...

Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer

This phase I/Ib trial studies the side effects and best dose of CB-839 HCl when given together with sapanisertib in treating patients with non-small cell lung cancer that has spread to oth...

Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer

This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and to see how well they work when given together in treating patients with squamous cell lung cance...

PubMed Articles [19826 Associated PubMed Articles listed on BioPortfolio]

Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study.

Although docetaxel plus ramucirumab has shown superior treatment efficacy over docetaxel monotherapy for patients with non-small cell lung cancer (NSCLC), the high rate of febrile neutropenia (FN) pre...

Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy.

Non-small-cell lung cancer (NSCLC) is a heterogeneous disease. Front-line therapy may affect responses to subsequent treatment regimens, thus influencing second-line therapy decision making. In the ra...

Neoadjuvant Dose-Modified Docetaxel in Squamous Cell Carcinoma of the Head and Neck: A Phase 3 Study.

Evaluate the efficacy and safety of dose modified docetaxel plus cisplatin and 5-fluorouracil (TPF) in Chinese patients with squamous-cell carcinoma of the head and neck (SCCHN).

Phase II study of ramucirumab and docetaxel for previously treated non-small cell lung cancer patients with malignant pleural effusion: Protocol of PLEURAM study.

Anti-vascular endothelial growth factor therapy has been shown to be effective in non-small cell lung cancer (NSCLC) patients with malignant pleural effusion (MPE); however, there are no data to sugge...

Integrated evaluation of clinical, pathological and radiological prognostic factors in squamous cell carcinoma of the lung.

Little is known about prognostic factors for lung squamous cell carcinoma (SCC). We aimed to explore radiologic and clinical factors affecting prognosis and to compare the prognosis of both central an...

Medical and Biotech [MESH] Definitions

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A carcinoma derived from stratified squamous epithelium. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A mixed adenocarcinoma and squamous cell or epidermoid carcinoma.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

More From BioPortfolio on "Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial)"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Searches Linking to this Trial