What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors such as pembrolizumab, nivolumab, and durvalumab, often combined with chemotherapy. Known side effects of these treatments can range from mild to severe and include fatigue, rash, diarrhea, and pruritus. More serious adverse events may involve pneumonitis, hepatitis, endocrinopathies, and colitis. Chemotherapy-related side effects often include nausea, vomiting, hair loss, and increased risk of infection due to bone marrow suppression. Combination therapies may increase the likelihood and severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that are relevant to overcoming resistance to Anti-PD-1/PD-L1 therapies. Pembrolizumab, nivolumab, and atezolizumab are notable checkpoint inhibitors that have received approval. Pembrolizumab can be used alone or in combination with chemotherapy for advanced NSCLC, while nivolumab is often combined with ipilimumab. Atezolizumab has been approved for use with chemotherapy and bevacizumab in specific cases. These treatments aim to enhance the immune response against cancer cells and are pivotal in managing NSCLC.

What other types of research exist?

Promising novel alternatives for overcoming resistance to anti-PD-1/PD-L1 therapies in NSCLC patients include combination therapies such as ramucirumab plus pembrolizumab, which has shown improved overall survival in clinical trials. Additionally, cabozantinib, with or without atezolizumab, is being evaluated for its activity in patients previously treated with immune checkpoint inhibitors. Further data from ongoing phase III trials are needed to confirm these approaches.

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DNA Damage Response Inhibitor

Novel Anti-Cancer Agents for Non-Small Cell Lung Cancer (HUDSON Trial)

Phase 2

Waitlist Available

Led By John Heymach, M.D, Ph.D

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing

Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed

Must not have

Patients whose tumour samples have targetable alterations in EGFR and/or ALK at initial diagnosis are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded

Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through to study completion, up to 4.5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing several new treatments for advanced lung cancer in patients who haven't responded to standard therapies. It aims to find out which new treatments are effective and safe.

Who is the study for?

This trial is for adults with advanced NSCLC who've had disease progression after anti-PD-1/PD-L1 therapy and platinum-doublet chemotherapy. They should be in good physical condition, not pregnant or breastfeeding, willing to use birth control, and have no severe allergies to study drugs or history of certain immune disorders.

What is being tested?

The trial tests multiple treatments like trastuzumab deruxtecan, cediranib, and others on patients with metastatic NSCLC post anti-PD-1/PD-L1 therapy failure. It's an open-label Phase II study assessing the efficacy and safety of these novel agents.

What are the potential side effects?

Potential side effects may include allergic reactions to treatment components, fatigue, nausea, risk of infection due to immune system impact from monoclonal antibodies used in some treatments.

Eligibility Criteria

Inclusion Criteria

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

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My NSCLC is getting worse and has spread or come back.

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I have at least one tumor that can be measured, including any that have grown after radiation.

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I am mostly active and my doctor expects me to live at least 12 more weeks.

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I am post-menopausal or not pregnant if pre-menopausal.

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I am 18 years old or older.

Exclusion Criteria

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

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My cancer does not have specific genetic changes in EGFR, ALK, ROS1, BRAF, MET, or RET.

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I am not pregnant, breastfeeding, and if capable of having children, I agree to use birth control.

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I am not allergic to the study drugs or similar medications.

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I do not have active infections like TB, hepatitis B or C, or HIV.

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I have or had an autoimmune or inflammatory disorder.

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I have spinal cord compression or brain metastases causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through to study completion, up to 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through to study completion, up to 4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through to study completion, up to 4.5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of the efficacy of each treatment by evaluation of objective response rate

Secondary study objectives

Best percentage change in tumour size using RECIST 1.1 assessment for the anti-tumour activity of each therapy

Disease control rate (DCR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.

Duration of response (DoR) using RECIST 1.1 assessment for the anti-tumour activity of each therapy.

+2 more

Other study objectives

Incidence of adverse events/serious adverse events to assess the safety and tolerability of each treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Group I: durvalumab + trastuzumab deruxtecanExperimental Treatment1 Intervention

durvalumab given in combination with trastuzumab deruxtecan (DS-8201a)

Group II: durvalumab + cediranibExperimental Treatment2 Interventions

durvalumab given in combination with cediranib (AZD2171)

Group III: durvalumab & AZD6738 (ceralasertib) (240 mg or 160 mg)Experimental Treatment1 Intervention

durvalumab in combination with twice daily 160 mg or 240 mg AZD6738 (D22-D28)

Group IV: durvalumab & AZD6738 (ceralasertib)Experimental Treatment2 Interventions

durvalumab given in combination with AZD6738 (D15-D28)

Group V: Durvalumab + vistusertibExperimental Treatment2 Interventions

Durvalumab given in combination with Vistusertib (AZD2014).

Group VI: Durvalumab + olaparibExperimental Treatment2 Interventions

Durvalumab given in combination with olaparib .

Group VII: Durvalumab + OleclumabExperimental Treatment2 Interventions

Durvalumab given in combination with Oleclumab

Group VIII: Durvalumab + AZD9150Experimental Treatment2 Interventions

Durvalumab given in combination with AZD9150.

Group IX: Durvalumab + AZD6738Experimental Treatment2 Interventions

Durvalumab given in combination with AZD6738.

Group X: AZD6738 (ceralasertib) monotherapyExperimental Treatment1 Intervention

AZD6738 (ceralasertib) given as monotherapy

Group XI: AZD6738 (ceralasertib) 7 days monotherapyExperimental Treatment1 Intervention

AZD6738 (ceralasertib) monotherapy on D1-7 of every 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oleclumab

2015

Completed Phase 2

~880

Durvalumab

2017

Completed Phase 2

~3750

AZD9150

2018

Completed Phase 1

~200

Olaparib

2007

Completed Phase 4

~2190

cediranib

2011

Completed Phase 3

~140

AZD6738

2015

Completed Phase 2

~130

0 / 11Eligibility 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 inhibit specific mutations or proteins that drive cancer growth, such as EGFR or ALK inhibitors. Immunotherapies, particularly immune checkpoint inhibitors like anti-PD-1/PD-L1 therapies (e.g., pembrolizumab, nivolumab), block proteins that prevent the immune system from attacking cancer cells. Chemotherapy, such as platinum-based regimens, kills rapidly dividing cells, including cancer cells. Understanding these mechanisms is crucial for NSCLC patients as it helps in selecting the most appropriate therapy based on the tumor's specific characteristics and the patient's overall health.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Emerging therapeutic agents for lung cancer.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.