About this trial

Lung cancer is one of the most common forms of cancer. One common type is non-small cell lung cancer (NSCLC). NSCLC happens when abnormal cells in the lungs grow too fast. This can stop the lungs from working normally. This study focuses on NSCLC in later stages (advanced). This means that the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable).

People with unresectable, advanced or metastatic NSCLC often get treatment with immunotherapy and/or platinum-based chemotherapy (such as cisplatin or carboplatin). Immunotherapy helps the body's germ-fighting (immune) system fight cancer. Chemotherapy kills cancer cells or slows their growth. Over time, these treatments may stop working and the cancer can get worse.

Researchers are looking for ways to make immunotherapy work better. One approach is to help the immune system recognize cancer more easily by activating certain cells, called T cells, to attack and kill the tumor cells. TAK-928 is designed to attach to T cells in the tumor and make them more active and abundant. This may help the body fight the cancer and destroy tumor cells.

The main aim of this study is to learn how well TAK-928 works and compares with the usual treatment (also called standard of care), docetaxel, in adults with unresectable, advanced or metastatic NSCLC. Another aim is to learn how safe TAK-928 is in adults with NSCLC.

The participants can be treated for up to 2 years (24 months) depending on how a participant responds, side effects, or other reasons. Researchers will check a participant's condition until the treatment is ended.

During the study, participants will visit the study clinic several times.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be able to understand and willing to sign the written informed consent form (ICF), be able to comply with the visit schedule and related procedures specified in the protocol.

Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater. For Japan-specific safety run-in (SRI) part of the trial, participants must be Japanese residing in Japan.

Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC. Mixed small cell carcinoma, or other pathological components are excluded.

Provide formalin-fixed tumor tissue specimen. Fresh biopsies are preferred but archival specimens collected within 2 years before signing the informed consent form are acceptable (blocks or 10-15 unstained slides sectioned 4-5 microns in thickness, if tissue slides, they must be sectioned from blocks less than or equal to (<=) 2 months from date of consent). Formalin-fixed paraffin-embedded (FFPE) blocks are preferred for submission; slides should be sent only if there is a local regulation preventing submission of the FFPE block. Ideally, the archival specimen should be collected subsequent to the most recent systemic therapy.

Disqualifiers

Women who are pregnant or breastfeeding, or intending to become pregnant before, during, or within 6 months after the last dose of any trial intervention. WOCBP not using and/or not willing to use at least 1 form of highly effective method of contraception and 1 barrier method of contraception or fertile men with WOCBP partner(s) not using and/or not willing to use at least 1 form of acceptable contraception. Note: If in the investigator's judgment, the participant may be pregnant based on the physician's medical interview or other information, the participant will be excluded from the trial irrespective of a negative pregnancy test.

Epidermal growth factor receptor (EGFR): including exon 19 deletion, exon 21 L858R, exon 20 T790M, exon 20 S768I, exon 21 L861Q, exon 18 G719X, and exon 20 insertion mutations.

Kirsten rat sarcoma virus (KRAS) G12C mutation.

Anaplastic lymphoma kinase (ALK) rearrangement.

Trial design

Design model

Parallel

Treatments tested in this trial

TAK-928
Drug
TAK-928 will be administered by IV infusion.
Control Arm
Drug
Comparator product will be administered by IV infusion.

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: TAK-928Experimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Global Part: Confirmed Objective Response Rate (cORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1

cORR is defined as the proportion of participants with confirmed objective response rate (complete response \[CR\] or partial response \[PR\]) per RECIST V1.1 CR is defined as complete disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to less than (\<) 10 mm. PR is defined as at least a 30 percent decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.

Time frame

Up to 26 months

2

Global Part: Overall Survival (OS)

To compare the overall survival (OS) of TAK-928 (treatment group) versus docetaxel (control group) in participants with unresectable locally advanced or metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

Time frame

Up to 26 months

3

SRI Part: Percentage of Participants with Dose-limiting Toxicities (DLTs)

DLT will be defined as any of the adverse events (AEs) specified in the protocol that occur within the DLT observation period, is not attributable to disease or other extraneous factors and potentially related to the intervention following the first dose. Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

Time frame

Up to 28 days after first dose (Day 1)

4

SRI Part: Percentage of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Immune-Related Adverse Events (irAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation and Deaths

AE: Any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not there is a causal relationship with any trial intervention, including, but not limited to, following: Exacerbation of pre-existing medical conditions/diseases (including worsening of symptoms, signs, laboratory abnormalities) temporally associated with the use of trial intervention; any newly developed adverse medical conditions (including symptoms, signs and newly diagnosed diseases) and clinically significant abnormal laboratory values or results. TEAE: Any AE that starts after the first administration of study drug. SAE: Any untoward medical occurrence that meets at least one of the following criteria: Results in death; is life threatening; requires inpatient hospitalization or prolongation of hospitalization. irAEs may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously.

Time frame

From screening up to 26 months

Secondary outcomes

1

Global and SRI Part: Objective Response Rate (ORR) as Assessed by Investigator per RECIST V1.1

The proportion of participants with a best overall response of complete response (CR) or partial response (PR), per RECIST v1.1.

Time frame

Up to 26 months

2

Global Part: Progression-free survival (PFS), as Assessed by BICR and Investigator per RECIST V1.1

Investigator and BICR assessed PFS per RECIST v1.1.

Time frame

Up to 26 months

3

Global Part: Disease Control Rate (DCR) as Assessed by BICR and Investigator per RECIST V1.1

The proportion of participants who achieve CR, PR, or stable disease (SD) per RECIST v1.1.

Time frame

Up to 26 months

4

Global Part: Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST V1.1

Time of first documented CR or PR to the time of disease progression or death.

Time frame

Up to 26 months

Locations44

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China

United States

A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts