Radiation Therapy for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
1
Effectiveness
2
Safety
Brigham and Women's Hospital, Boston, MA
Carcinoma, Non-Small-Cell Lung+8 More
Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a combination of immunotherapy and radiation therapy is more effective than either treatment alone.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Stage IV Non-Small Cell Lung Cancer AJCC v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7
  • Metastatic Colorectal Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Radiation Therapy will improve 1 primary outcome, 7 secondary outcomes, and 1 other outcome in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of From date of randomization until objective disease progression or death, whichever occurs first, assessed up to 2 years.

Year 2
Progression-free survival (PFS)
Year 2
Overall survival (OS)
Up to 2 years
Incidence of adverse events
Local control rate and abscopal response rates
Objective response per immune-related response (irORR) criteria
Overall response rate
Patient reported symptomatic adverse events(AEs)
Prognostic effect of PD-L1 expression
Prognostic effect of T-cell infiltration

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Arm B (tremelimumab, Durvalumab, RT)

This trial requires 180 total participants across 3 different treatment groups

This trial involves 3 different treatments. Radiation Therapy is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm B (tremelimumab, Durvalumab, RT)Patients receive tremelimumab and durvalumab and as in Arm A. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Arm C (tremelimumab, durvalumab, and RT)Patients receive tremelimumab and durvalumab and as in Arm A. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Arm A (tremelimumab, durvalumab)Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7080
Tremelimumab
Not yet FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Non-Small-Cell Lung or one of the other 8 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
for metastatic disease Cohort 2 will include patients with metastatic colorectal cancer who have progressed after at least one line of chemotherapy. show original
Patients in cohort 1 must have histologically or cytologically confirmed non-small cell lung cancer, and patients in cohort 2 must have histologically or cytologically confirmed colorectal cancer. show original
before enrollment onto the study In order to be enrolled in the study, at least 21 days must have passed since you received prior systemic therapy (chemotherapy or radiation). show original
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%) and life expectancy greater than 6 months; furthermore, enrollment of patients with greater than 10 measurable lesions is allowable but not encouraged. show original
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1.5 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Cohort 1 (NSCLC): Patients must have evidence of radiologic or clinical disease progression during previous treatment with systemic PD-1 directed therapy and/or have been deemed not to derive clinical benefit from PD-1 directed treatment; this includes patients who demonstrated an initial response and subsequent progression; no prior treatment with chemotherapy or targeted agents are required; intervening therapy is allowed between previous PD-1 directed treatment and there is no required interval from prior PD-1 treatment required; PD-1 directed treatment includes treatment with antibodies targeting the PD-1 receptor such as pembrolizumab or nivolumab, as well as PD-L1 targeted antibodies such as MEDI4736 (durvalumab), atezolizumab and avelumab; these agents may have been administered as part of a clinical trial
Hemoglobin (Hgb) >= 9 g/dl
A neutrophil count of 1,500 or more means that you have an increased risk of infection. show original
Platelets >= 100,000/mcL
People who need a blood transfusion or growth factors to live cannot be screened for this study show original

Patient Q&A Section

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

How many people get carcinoma, non-small-cell lung a year in the United States?

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Approximately 50,000 new cases of carcinoma or non-small-cell lung are diagnosed each year in the United States. This is an increase from the 35,000 in 1968 and 10,000 in 1970 reported nationally. The annual increase and higher percentage of Blacks in diagnosed carcinoma cases suggests the need for further studies.

Unverified Answer

What is carcinoma, non-small-cell lung?

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NSCLC includes lung adenocarcinoma (33%), squamous cell carcinoma (26%), large cell carcinoma (10%) and adenocarcinoma combined with squamous cell carcinoma (9%). Most NSCLC patients present with inoperable disease. Adenocarcinoma is the most frequent type and the most common cause of cancer-related death.

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What causes carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung is the most common lung cancer, and more common among younger people and men who are current cigarette or former tobacco smokers.

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Can carcinoma, non-small-cell lung be cured?

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stage I NSCLC can be cured with surgery, postoperative adjuvant therapy, or both. Stage II-III disease, however, is largely incurable, although some tumors can be cured and progression can be prevented by chemotherapy prior to surgery. Stage IV NSCLC typically progresses, but rarely if at all becomes wholly eradicated if complete surgical resection and adjuvant chemotherapy are performed.

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What are the signs of carcinoma, non-small-cell lung?

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The most accurate sign of respiratory-related carcinoma is an elevated serum pneumoniticcarrier carboxyhemoglobin level. Other signs of carcinoma, non-small-cell lung include dyspnea, cough, heaviness (mixed), weight loss, fever, blood in sputum, hemoptysis (bloody), coughing blood, hemoptysis without a cough, neck mass, chest fullness (>2 weeks), shortness of breath (>3 weeks), or pleural effusion (>2 weeks).

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

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There is some evidence that, overall, patients with carcinoma have a better survival rate when they undergo surgery than medical treatment, though the discrepancy is small. There is no clear overall survival difference between surgery and medical therapies. Furthermore, there were no significant differences between medical and surgical treatments for certain subsets of patients with specific cancer types. The type or degree of surgical resection, surgical lymph node dissection, and timing of surgery influence survival; there may be the need for additional clinical trials involving different treatments to decide how best to manage and treat lung cancer.

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What are the common side effects of radiation therapy?

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RT in patients diagnosed with cancer is a safe and effective treatment. Results from a recent clinical trial showed for the first time that RT can cause cutaneous side effects which are mostly reversible if promptly treated.

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Have there been other clinical trials involving radiation therapy?

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This review confirms that radiotherapy in conjunction with chemotherapy is an effective antitumor treatment. A recent metaanalysis of the current literature supports the fact that radiation therapy is a [potential treatment]] for many common forms of cancer.

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Is radiation therapy typically used in combination with any other treatments?

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Patients with small-stage endometrioid uterine cancer typically receive only radiotherapy or radiotherapy plus a chemotherapy or multimodality combination. The decision to use radiotherapy or chemotherapy vs chemotherapy alone depends on the type, location, and histology.

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Is radiation therapy safe for people?

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The majority of patients were managed adequately under the supervision of a radiation oncologist with or without radiographers, including patients with advanced stage, unfavorable prognostic factors, and comorbidities. Most patients receiving high-dose thoracic, or concomitant thoracic and abdominal, radiotherapy for early-stage NSCLC can expect improved outcomes from the addition of adjuvant radiotherapy-based therapy.

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Does radiation therapy improve quality of life for those with carcinoma, non-small-cell lung?

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For patients with NSCLC, RT is associated with substantial psychological benefit, though physical factors may partially offset this. For carcinoma, NSCLC patients treated with RT have good quality of life compared with patients treated with postoperative RT, and overall survival is equivalent. Radiation appears to be a cost-effective treatment strategy for NSCLC.

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Does carcinoma, non-small-cell lung run in families?

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In this analysis, familial carcinoma, non-small-cell lung patients had markedly and statistically significantly lower rates of current smoking than controls. The patients also suffered a higher degree of tobacco related disease history, despite relatively equal amounts of smoking among the 2 groups. Patients with familial carcinoma, non-small-cell lung suffer from the disease for earlier ages, are less likely to be asymptomatic and have higher prevalence rates of bronchiectasis compared to control. It should be considered that familial carcinoma, non-small-cell lung patients should be examined carefully when seeking medical treatment or participation in clinical trials.

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