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Chemotherapy

Nivolumab for Non-Small Cell Lung Cancer

Q: How many people are enrolled in this investigation?

This clinical trial is no longer accepting participants, having been posted on December 20th 2017 and last edited September 14th 2022. Nevertheless, there are presently 4160 trials that are actively enrolling candidates with carcinoma non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, as well as 1765 studies looking for individuals to participate in Nivolumab treatment.

Q: What medical conditions have been alleviated with the use of Nivolumab?

Nivolumab is a well-known treatment for advanced <a href="https://www.withpower.com/clinical-trials/testicular-cancer">testicular cancer</a>, as well as smaller cell lung cancers (<a href="https://www.withpower.com/clinical-trials/sclc">sclc</a>), malignant neoplasms, and inoperable melanomas.

Q: Has the United States Food and Drug Administration (FDA) sanctioned Nivolumab?

Due to its lack of efficacy data points, Nivolumab was given a safety score of 2. Nevertheless, there are some clinical results that demonstrate the drug is safe for use in Phase 2 trials.

Q: Is the recruitment process open for this clinical experiment?

At present, this clinical trial is not recruiting participants. The entry was originally posted in December of 2017 and last edited on September 14th 2022. If you are searching for other studies, there are 4160 trials targeting carcinoma non-small-cell <a href="https://www.withpower.com/clinical-trials/lung-cancer">lung cancer</a> patients as well as 1765 surveys seeking individuals undergoing Nivolumab therapy.

Phase 2

Waitlist Available

Led By Rita Axelrod, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study Summary

This trial is testing Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride to treat patients with stage I-IIIA non-small cell lung cancer.

Eligible Conditions

Lung Carcinoma
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year 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 (mpCR) defined as < 10% viable tumor

Secondary outcome measures

Incidence of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Overall clinical response

Overall survival

+1 more

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

Hypertension

Chills

Hyperkalaemia

Dehydration

Hyperglycaemia

Blood alkaline phosphatase increased

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Rash maculo-papular

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

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Cancer pain

Small intestinal haemorrhage

Confusional state

Pneumothorax

Atrial flutter

Femur fracture

Bone pain

Neoplasm progression

Pericardial effusion malignant

Circulatory collapse

Hypercalcaemia

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

2Treatment groups

Experimental Treatment

Group I: Cohort I (nivolumab, cisplatin, pemetrexed disodium)Experimental Treatment3 Interventions

Patients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity

Group II: Cohort I (nivolumab, cisplatin, gemcitabine hydrochloride)Experimental Treatment2 Interventions

Patients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Pemetrexed

FDA approved

Cisplatin

FDA approved

Gemcitabine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,897 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,129,018 Total Patients Enrolled

Rita Axelrod, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

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

How many people are enrolled in this investigation?

"This clinical trial is no longer accepting participants, having been posted on December 20th 2017 and last edited September 14th 2022. Nevertheless, there are presently 4160 trials that are actively enrolling candidates with carcinoma non-small cell lung cancer, as well as 1765 studies looking for individuals to participate in Nivolumab treatment."

Answered by AI

What medical conditions have been alleviated with the use of Nivolumab?

"Nivolumab is a well-known treatment for advanced testicular cancer, as well as smaller cell lung cancers (sclc), malignant neoplasms, and inoperable melanomas."

Answered by AI

Has the United States Food and Drug Administration (FDA) sanctioned Nivolumab?

"Due to its lack of efficacy data points, Nivolumab was given a safety score of 2. Nevertheless, there are some clinical results that demonstrate the drug is safe for use in Phase 2 trials."

Answered by AI

Is the recruitment process open for this clinical experiment?

"At present, this clinical trial is not recruiting participants. The entry was originally posted in December of 2017 and last edited on September 14th 2022. If you are searching for other studies, there are 4160 trials targeting carcinoma non-small-cell lung cancer patients as well as 1765 surveys seeking individuals undergoing Nivolumab therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery

2017. "Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03366766.