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Alkylating agents

Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Tina Cascone

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance >= 50 mL/min

Histologically or cytologically confirmed previously untreated non-small cell lung cancer

Must not have

Subjects with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing immunotherapy and chemotherapy drugs to see if they're effective in treating non-small cell lung cancer.

Who is the study for?

This trial is for patients with untreated stage I-IIIA non-small cell lung cancer who are suitable for surgery, have good organ function and performance status (able to carry out daily activities), and can provide consent. They must not be pregnant, on current cancer therapy, or have severe allergies to monoclonal antibodies or certain chemotherapy drugs.

What is being tested?

The study tests how well nivolumab works alone or combined with ipilimumab or chemotherapy (cisplatin, docetaxel, pemetrexed) in treating these lung cancer patients. It compares the effectiveness of immunotherapy versus traditional chemotherapy in stopping tumor growth.

What are the potential side effects?

Possible side effects include immune-related reactions that may affect organs, infusion reactions from the antibodies used, typical chemo side effects like nausea and hair loss, fatigue, blood disorders such as low white cell count increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My lung cancer diagnosis was confirmed through lab tests and has not been treated yet.

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I am fully active or can carry out light work.

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My cancer is in stage IA or IB and is less than 4 cm.

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My stage IIIA cancer affects no more than one lymph node area in my chest.

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My lymph nodes in specific areas have been checked to rule out advanced cancer.

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My cancer has features of neuroendocrine differentiation.

Exclusion Criteria

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

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have tested positive for HIV/AIDS.

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I have a serious illness besides cancer.

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I am currently undergoing cancer treatment or participating in a drug trial.

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I have hearing loss as confirmed by an audiologist.

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I have received treatments like chemotherapy or radiation for my current lung cancer.

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I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgical procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Major pathologic response (mPR)

Secondary study objectives

CD8 positive (+) tumor infiltrating lymphocytes (TILs) quantification

Evaluate blood, tissue, and stool-based biomarkers

Evaluate response assessed by imaging studies

+6 more

Other study objectives

Identification of novel prognostic and predictive markers

Modulation of markers by induction immunotherapy

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (ipilimumab, nivolumab, chemotherapy)Experimental Treatment6 Interventions

Patients receive ipilimumab IV over 90 minutes on day 1, nivolumab IV over 30 minutes on days 1, 22, and 43, and cisplatin (or carboplatin) IV over 2 hours on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour or pemetrexed IV over 10 minutes on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (nivolumab, cisplatin, docetaxel, pemetrexed)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes and cisplatin IV over 2 hours on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour or pemetrexed IV over 10 minutes on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (nivolumab, ipilimumab)Experimental Treatment2 Interventions

Participants receive nivolumab as in Arm A and receive ipilimumab IV over 90 minutes on day 1 in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (nivolumab)Experimental Treatment1 Intervention

Participants receive nivolumab IV over 60 minutes on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Carboplatin

FDA approved

Cisplatin

FDA approved