What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like docetaxel and pemetrexed can cause side effects such as nausea, fatigue, hair loss, and hematologic toxicity. Targeted therapies, such as tyrosine kinase inhibitors, may lead to skin rashes, diarrhea, and liver dysfunction. Immunotherapies like pembrolizumab and atezolizumab can result in immune-related adverse events, including pneumonitis, colitis, and endocrinopathies. DS-1062a, an investigational drug, is being evaluated for safety and tolerability, with potential side effects similar to other targeted therapies.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) similar to the investigational drug DS-1062a include immune checkpoint inhibitors and targeted therapies. Pembrolizumab (Keytruda) and atezolizumab (Tecentriq) are immune checkpoint inhibitors that target the PD-1/PD-L1 pathway to boost the immune system's response against cancer. Targeted therapies such as osimertinib (Tagrisso) for EGFR mutations and crizotinib (Xalkori) for ALK rearrangements are also approved, focusing on specific genetic mutations to inhibit tumor growth.

What other types of research exist?

Promising alternatives to DS-1062a for NSCLC patients include: 1) Tucatinib, capecitabine, and trastuzumab combination, which has shown improved progression-free survival and overall survival in patients with HER2-positive metastatic breast cancer, including those with brain metastases. 2) Pembrolizumab combined with chemotherapy, which has demonstrated efficacy in the KEYNOTE-189 trial for advanced nonsquamous NSCLC. 3) Atezolizumab plus bevacizumab, carboplatin, and paclitaxel (ABCP regimen), which has shown improved progression-free survival and overall survival in the IMpower 150 trial for advanced nonsquamous NSCLC.

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Monoclonal Antibodies

DS-1062a for Non-Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically documented unresectable or metastatic HNSCC that was previously treated with 1-3 prior lines of therapy including platinum and ICI (in combination or sequential), in the advanced or metastatic setting

Has a pathologically documented unresectable advanced NSCLC disease not amenable to curative therapy

Must not have

Has unresolved toxicities from previous anticancer therapy

Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)

Awards & highlights

Summary

This trial is studying a new drug, DS-1062a, for safety and tolerability in people with NSCLC that has not been cured by other treatments. The trial will be in two parts, with the first part looking at dose escalation and the second part looking at additional solid tumors. The trial is expected to last approximately 6 years and will be conducted in the United States and Japan.

Who is the study for?

This trial is for adults with various advanced solid tumors, including non-small cell lung cancer and breast cancer, that have not responded to standard treatments. Participants must have measurable disease, adequate organ function, agree to use contraception if of childbearing potential, and be willing to provide tissue samples. They should not have had certain prior treatments or conditions that would exclude them from the study.Check my eligibility

What is being tested?

The trial is testing a new drug called Datopotamab Deruxtecan (Dato-DXd) in humans for the first time. It includes dose escalation to find the safest dose and expansion phases across different tumor types over approximately six years. A sub-study compares steroid versus non-steroid mouthwash in preventing oral mucositis in participants receiving Dato-DXd.See study design

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea, blood disorders like low platelet count or anemia which could lead to bleeding or tiredness respectively; increased risk of infections due to immune system suppression; and possible inflammation of organs such as lungs leading to breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My head/neck cancer can't be removed by surgery and was treated with 1-3 therapies including platinum and immunotherapy.

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My advanced lung cancer cannot be removed by surgery.

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My breast cancer is advanced, cannot be surgically removed, and lacks hormone and HER2 receptors.

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My small cell lung cancer is advanced and was treated with specific drugs but not topotecan or irinotecan.

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I have never been treated with TROP2-targeted therapy.

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My cancer in the stomach or esophagus is advanced and was treated before, but it's not HER2 positive.

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My condition worsened after standard treatments or no standard treatment exists for it.

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I am 18 years old or older.

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I have not been treated with specific advanced cancer drugs, except T-DXd for HR-positive HER2-low breast cancer.

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My pancreatic cancer is advanced and was treated with at least one therapy before.

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My esophageal cancer cannot be removed by surgery and has been treated before with platinum-based chemotherapy.

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My cancer is advanced, cannot be surgically removed, and I've had treatment including an immune checkpoint inhibitor.

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My colorectal cancer is advanced and didn't respond to standard treatments but hasn't worsened in 6 months after irinotecan therapy.

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My ovarian cancer cannot be surgically removed, has returned or worsened within 6 months after platinum-based treatment.

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My ovarian, fallopian tube, or peritoneal cancer has returned or worsened 6 months after platinum chemotherapy.

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My breast cancer is HER2-low, hormone receptor positive, and was treated with T-DXd.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My endometrial cancer has come back or worsened after treatment, including at least one drug treatment.

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My blood and organs are functioning well enough for treatment.

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My cervical cancer has returned or worsened after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have side effects from past cancer treatments.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I do not have severe heart failure, uncontrolled heart rhythm problems, or very high blood pressure.

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I am allergic to certain medications, including steroids or ingredients in mouthwash.

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I have an active or uncontrolled hepatitis B or C infection.

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I have severe lung problems due to other lung diseases or conditions affecting my lungs.

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My cancer has spread to the lining of my brain and spinal cord.

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I am currently using oral or inhaled steroids for asthma, COPD, or another condition.

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I have mouth sores or infections, including thrush, right now.

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I have a serious eye condition affecting my cornea.

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I need medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stomatitis

Number of participants with adverse events (AEs)

Number of participants with dose-limiting toxicities

Secondary outcome measures

AUC during the dosing period (AUCtau)

Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)

Maximum concentration (Cmax)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion - All ParticipantsExperimental Treatment3 Interventions

All participants enrolled in the dose expansion part

Group II: Dose Escalation - All ParticipantsExperimental Treatment1 Intervention

All participants enrolled in the dose escalation part

0 / 31Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), work by blocking specific proteins that promote cancer cell growth, making them effective for patients with certain genetic mutations. Immunotherapies, like checkpoint inhibitors (e.g., nivolumab, pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. The investigational drug DS-1062a, a TROP2-directed antibody-drug conjugate, combines targeted therapy with chemotherapy by delivering a cytotoxic agent directly to cancer cells expressing the TROP2 protein. This targeted approach aims to increase efficacy while reducing systemic toxicity, offering a promising option for NSCLC patients who have not responded to other treatments.

Cancer Metastases from Lung Adenocarcinoma Disappeared After Molecular Targeted Therapy: A Successfully Clinical Treatment Experience.