Is NCT04585490 recruiting in Stanford, CA?

Yes, NCT04585490 is currently recruiting participants at its Stanford, CA location. This non small cell lung cancer clinical trial is actively enrolling qualified participants.

How do I join the non small cell lung cancer clinical trial in Stanford?

To join this clinical trial in Stanford, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Stanford clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non Small Cell Lung Cancer Clinical Trial in Stanford, CA

Who Can Participate

Inclusion Criteria

Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment.

For stage III or recurrent disease, must have completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy +/- 10%). Must not have known progression of disease.

Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose of durvalumab. (Patients may sign consent for study before start of durvalumab, but confirm eligibility and enroll only after first dose of durvalumab is received).

Able to potentially receive further consolidation chemotherapy plus durvalumab and tremelimumab, but not be currently intended to receive additional systemic consolidation chemotherapy apart from this durvalumab.

Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis

Aged 18 years or older

Weight \> 30kg

Life expectancy ≥ 12 weeks

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Absolute neutrophil count \> 1.0 x 109/L (1000/mm3)

Platelets \> 75 x 109/L (100,000/mm3)

Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L)

Measured creatinine clearance \> 40 mL/min, by either 24 hour urine collection or the Cockcroft Gault formula Males: Mass(kg) x (140-Age) / 72 x serum creatinine (mg/dL) Females: Mass(kg) x (140-Age) x 0.85 / 72 x serum creatinine (mg/dL)

Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.

aspartate aminotransferase (AST) (SGOT)/Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 5 x ULN

Ability to understand and the willingness to sign the written IRB approved informed consent document.

Exclusion Criteria

Involvement in the planning and/or conduct of the study 2\. Previous enrollment or randomization in the present study 3\. Received Investigational product as part of another clinical study 4\. Mixed small cell and non small cell lung cancer histology 5\. History of another primary malignancy and currently undergoing active treatment. Exception: May participate if receiving adjuvant endocrine therapy for breast or prostate cancer. 6\. Current or prior use of immunosuppressive medication within 14 days before enrollment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed. 7\. Any unresolved toxicity CTCAE \> Grade 2 from the prior chemoradiation therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

Subjects with Grade ≥ 2 neuropathy will be evaluated on a case by case basis after consultation with the Protocol Director / Principal Investigator

Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab may be included (ie, hearing loss) only after consultation with the Protocol Director / Principal Investigator. 8\. Any prior Grade ≥ 3 immune related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \> Grade 1) that may limit subject from continuing durvalumab during the study 9\. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of study drug. 10\. Active or prior documented autoimmune or inflammatory disorders which is likely to limit the subjects ability to continue durvalumab on the study (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis; etc\]). Those with history of autoimmune or inflammatory disorders who are currently tolerating durvalumab may be eligible to participate with approval from the PI. The following are also exceptions to this criterion:

Vitiligo or alopecia

Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement

Chronic skin condition not requiring systemic therapy

Celiac disease controlled by diet alone 11\. History of primary immunodeficiency 12\. History of organ transplant requiring therapeutic immunosuppression 13\. History of hypersensitivity to carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel that is likely to prevent re-administration of these agents 14\. Active infection including but not limited to:

Grade 3 or higher clinically significant infection

Active known Hepatitis B \[known positive results for HBV surface antigen (HBsAg) within 2 months prior to enrollment\]. EXCEPTION: Subjects with a past or resolved HBV infection, defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg are eligible

Active known Hepatitis C (HCV). EXCEPTION: Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA

Active known tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).

Active known HIV infection 15\. Receipt of live attenuated vaccine within 30 days prior to the first dose of concurrent chemotherapy and durvalumab. Note: Subjects, if enrolled, should not receive live vaccine through 30 days after the last dose of chemotherapy concurrent with durvalumab. 16\. Uncontrolled intercurrent illness, including but not limited to:

Ongoing or active infection

Symptomatic congestive heart failure

Uncontrolled hypertension

Unstable angina pectoris

Cardiac arrhythmia

Interstitial lung disease

Serious chronic gastrointestinal conditions associated with diarrhea

Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent. 17\. Female subjects who are pregnant or breast feeding; or subjects of reproductive potential of any gender who are not employing or who do not agree to employ an effective method of birth control prior to trial enrollment.ollment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stanford?

Yes, this clinical trial (NCT04585490) has an active research site in Stanford, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non Small Cell Lung Cancer Treatment Options in Stanford, CA

If you're searching for non small cell lung cancer treatment options in Stanford, CA, this clinical trial (NCT04585490) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stanford research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced non small cell lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non small cell lung cancer clinical trials near you to find additional studies recruiting in your area.

Non Small Cell Lung Cancer Clinical Trial in Stanford, CA

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About This Non Small Cell Lung Cancer Study in Stanford