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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Major pathologic response (mPR)

Secondary outcome measures

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

Evaluate blood, tissue, and stool-based biomarkers

Evaluate response assessed by imaging studies

+8 more

Other outcome measures

Identification of novel prognostic and predictive markers

Modulation of markers by induction immunotherapy

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Blood alkaline phosphatase increased

Chills

Hypertension

Dehydration

Hyperkalaemia

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

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

Nivolumab

FDA approved

Pemetrexed

FDA approved

Docetaxel

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,680 Total Patients Enrolled

Tina CasconePrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

28 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03158129 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Arm B (nivolumab, ipilimumab), Arm D (ipilimumab, nivolumab, chemotherapy), Arm C (nivolumab, cisplatin, docetaxel, pemetrexed), Arm A (nivolumab)

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03158129 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03158129 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in the examination thus far?

"This trial is now closed for recruitment. Initially posted on June 9th 2017, the last update was made October 24th 2022. Those seeking participation in a clinical study should consider the 3656 active trials recruiting patients with non-small cell lung carcinoma and 2098 studies searching for volunteers to test Nivolumab."

Answered by AI

Has the FDA officially certified Nivolumab for consumer use?

"Taking into account that Nivolumab is being tested in Phase 2, our team has judged its safety profile to be a score of 2 since there are limited data points demonstrating efficacy."

Answered by AI

In what situations is Nivolumab commonly prescribed?

"Nivolumab is typically given to patients with metastatic bladder cancer, but has also been demonstrated to combat a variety of other ailments including advanced directives, small cell lung cancer (sclc), and even testicular cancer in its more progressed forms."

Answered by AI

Is enrollment for this experiment still available to the public?

"As per the information housed on clinicaltrials.gov, this specific medical trial is not actively seeking participants. Initially posted June 9th 2017 and revised October 24th 2022, no further enrolment is required; however 5754 other trials are recruiting now."

Answered by AI

Recent research and studies

Nature MedicineJournal

Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Operable Non-small Cell Lung Cancer: The Phase 2 Randomized NEOSTAR Trial

Cascone, Tina, William N. William Jr, Annikka Weissferdt, Cheuk H. Leung, Heather Y. Lin, Apar Pataer, Myrna C. B. Godoy, et al.. 2021. “Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Operable Non-small Cell Lung Cancer: The Phase 2 Randomized NEOSTAR Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-01224-2.

Nature CommunicationsJournal

Nodal Immune Flare Mimics Nodal Disease Progression Following Neoadjuvant Immune Checkpoint Inhibitors in Non-small Cell Lung Cancer

Cascone, Tina, Annikka Weissferdt, Myrna C. B. Godoy, William N. William Jr., Cheuk H. Leung, Heather Y. Lin, Sreyashi Basu, et al.. 2021. “Nodal Immune Flare Mimics Nodal Disease Progression Following Neoadjuvant Immune Checkpoint Inhibitors in Non-small Cell Lung Cancer”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-021-25188-0.

clinicaltrials.govStudy

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

2017. "Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03158129.